MS-HDtDCS: Treatment of Cognitive Deficits in Multiple Sclerosis With High-Definition Transcranial Direct Current Stimulation

Sponsor

The University of Texas at Dallas (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05958381

Collaborator

University of Texas Southwestern Medical Center (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., presupplementary motor area) thought to aid in memory will improve verbal retrieval in multiple sclerosis patients. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures. Additionally, the study will examine the degree to which baseline assessments of cognition and concussion history predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis, Relapsing-Remitting	Device: Transcranial Direct Current Stimulation Device: Sham transcranial direct current stimulation	Phase 1/Phase 2

Detailed Description

Using two treatment arms, the study will examine improvement of verbal retrieval and other cognitive deficits associated with multiple sclerosis by comparing (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 10 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and immediate and 2-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 10 sessions and will be re-evaluated at immediate and 2-month follow-up testing sessions.

Patients with multiple sclerosis and observed cognitive deficits will be randomly assigned to one of the two treatment arms (and re-assigned for the second round of intervention, as described above). Primary outcome verbal retrieval measures, secondary neuropsychological and electroencephalography (EEG) measures, and prescreening assessments for study concussion history and contraindications for treatment will be collected prior to being assigned to a treatment arm (i.e., baseline).

Primary outcome verbal retrieval measures and secondary neuropsychological and electroencephalography (EEG) measures will be at baseline and two times following treatment competition (i.e., immediate and 2-months). For participants selected for the second round of intervention, primary outcome verbal memory measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected again two times immediately following completion of the last treatment and 2-months afterward.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomly assigned to 1 of 2 treatment arms: (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 15 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and immediate and 2-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 15 sessions and will be and re-evaluated at immediate- and 2-months follow-up testing sessions.Participants will be randomly assigned to 1 of 2 treatment arms: (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 15 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and immediate and 2-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 15 sessions and will be and re-evaluated at immediate- and 2-months follow-up testing sessions.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Participants, assessors, and technicians interacting with participants will be blind to assigned conditions. The software for the transcranial direct current system allows for maintaining blinds when uploading and running protocols.

Primary Purpose:

Treatment

Official Title:

Treatment of Cognitive Deficits in Multiple Sclerosis With High-Definition Transcranial Direct Current Stimulation

Anticipated Study Start Date :

Jul 30, 2023

Anticipated Primary Completion Date :

Jun 29, 2026

Anticipated Study Completion Date :

Jun 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transcranial direct current stimulation Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds. Other Names: tDCS 1 milliamp tDCS High definition tDCS High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10	Device: Transcranial Direct Current Stimulation Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds. Other Names: tDCS
Sham Comparator: Sham transcranial direct current stimulation Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.	Device: Sham transcranial direct current stimulation Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes. Other Names: Sham tDCS

Arm

Intervention/Treatment

Experimental: Transcranial direct current stimulation

Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds. Other Names: tDCS 1 milliamp tDCS High definition tDCS High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10

Device: Transcranial Direct Current Stimulation

Other Names:

tDCS

Sham Comparator: Sham transcranial direct current stimulation

Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.

Device: Sham transcranial direct current stimulation

Other Names:

Sham tDCS

Outcome Measures

Primary Outcome Measures

Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on Category Fluency from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., & Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.
Treatment group differences in change from Baseline to 2-months Post-Treatment on Category Fluency [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment]
Evaluation of treatment group differences in change on Category Fluency from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., & Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.
Treatment group differences in change from Baseline to 1-week Post-Treatment on COWAT [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on COWAT from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., & Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.
Treatment group differences in change from Baseline to 2-months Post-Treatment on COWAT [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on COWAT from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated Benton, L.A., Hamsher, K., & Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.

Secondary Outcome Measures

Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part A) [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on the Trail Making Test (Part A) from baseline to 1-week post-treatment. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part B) [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on the Trail Making Test (Part B) from baseline to 1-week post-treatment. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Delis Kaplan Color Word Interference Test [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on the Delis Kaplan Color Word Interference Test from baseline to 1-week post-treatment. Metric: Time to Name Items Delis, D.C., Kaplan, E., & Kramer, J.H., (2001). Delis-Kaplan Executive Function System. San Antonio, TX: The Psychological Corporation.
Treatment group differences in change from Baseline to 1-week Post-Treatment on on the Digit Span Forward [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on the on the Digit Span Forward from baseline to 1-week post treatment. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Span Backward [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on the Digit Span Backward from baseline to 1-week post treatment. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Treatment group differences in change from Baseline to 1-week Post-Treatment on on the the Rey-Osterrieth Complex Figure Test [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on the Rey-Osterrieth Complex Figure Test from baseline to 1-week post treatment. Metric: Score Rey, A. (1941). L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). [The psychological examination in cases of traumatic encepholopathy. Problems.]. Archives de Psychologie, 28, 215- 285.
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Symbol Substitution Test [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on the on the the Digit Symbol Substitution Test from baseline to 1-week post treatment. Metric: Number of Items Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Grooved Pegboard Test [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on the Grooved Pegboard Test from baseline to 1-week post-treatment. Metric: Completion Time Matthews, C.G., and Klove, H. (1964). Instruction manual for the adult neuropsychology test. Madison. Wis: University of Wisconsin Medical School.
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval Test [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on the Semantic Object Retrieval Test from baseline to 1-week post-treatment. Metric: Number of Correct Names Retrieved Kraut, M.A., Cherry, B., Pitcock, C.B., Anand, R., Li, J. Vestal, L., Henderson, V.W., and Hart, J. Jr. (2007). The Semantic Object Retrieval Test (SORT) in amnestic cognitive impairment. Cogn. Behav. Neurol. 20, 62- 67.
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Boston Naming Test [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on the Boston Naming Test from baseline to 1-week post-treatment. Metric: Number of Items Correctly Named Kaplan, E., Goodglass, H., & Weintraub, S., (1983). Boston Naming Test (2nd ed.). Lea & Febiger: Philadelphia.
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Auditory Verbal Learning Test [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on the Auditory Verbal Learning Test from baseline to 1-week post-treatment. Metric: Number of Items Remembered Rey, A. (1964). L'examen clinique enpsychologie. Paris: Presses Universitaires de France.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part A) [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on the Trail Making Test (Part A) from baseline to 2-months post-treatment. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part B) [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on the Trail Making Test (Part B) from baseline to 2-months post-treatment. Metric: Time to Solution Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Delis Kaplan Color Word Interference Test [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on the Delis Kaplan Color Word Interference Test from baseline to 2-months post-treatment. Metric: Time to Name Items Delis, D.C., Kaplan, E., & Kramer, J.H., (2001). Delis-Kaplan Executive Function System. San Antonio, TX: The Psychological Corporation.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Forward [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on the on the Digit Span Forward from baseline to 2-months post-treatment. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Backward [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on the on the Digit Span Backward from baseline to 2-months post-treatment. Metric: Memory Span Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Rey-Osterrieth Complex Figure Test [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on the on the Rey-Osterrieth Complex Figure Test from baseline to 2-months post-treatment. Metric: Score Rey, A. (1941). L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). [The psychological examination in cases of traumatic encepholopathy. Problems.]. Archives de Psychologie, 28, 215- 285.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Symbol Substitution Test [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on the on the the Digit Symbol Substitution Test from baseline to 2-months post treatment. Metric: Number of Items Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Grooved Pegboard Test [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on the Grooved Pegboard Test from baseline to 2-months post-treatment. Metric: Completion Time Matthews, C.G., and Klove, H. (1964). Instruction manual for the adult neuropsychology test. Madison. Wis: University of Wisconsin Medical School.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval Test [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on the Semantic Object Retrieval Test from baseline to 2-months post-treatment. Metric: Number of Correct Names Retrieved Kraut, M.A., Cherry, B., Pitcock, C.B., Anand, R., Li, J. Vestal, L., Henderson, V.W., and Hart, J. Jr. (2007). The Semantic Object Retrieval Test (SORT) in amnestic cognitive impairment. Cogn. Behav. Neurol. 20, 62- 67.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Boston Naming Test [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on the Boston Naming Test from baseline to 2-months post-treatment. Metric: Number of Items Correctly Named Kaplan, E., Goodglass, H., & Weintraub, S., (1983). Boston Naming Test (2nd ed.). Lea & Febiger: Philadelphia.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Auditory Verbal Learning Test [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on the Auditory Verbal Learning Test from baseline to 2-months post-treatment. Metric: Number of Items Remembered Rey, A. (1964). L'examen clinique enpsychologie. Paris: Presses Universitaires de France.
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Inhibition Task EEG spectral power [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on the Semantic Inhibition Task EEG from baseline to 1-week post-treatment. Metric: EEG spectral (theta) power Brier et al. (2010). Frontal theta and alpha power and coherence changes are modulated by semantic complexity in Go/NoGo tasks. International Journal of Psychophysiology, 78, 215-224.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Inhibition Task EEG spectral power [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on the Semantic Inhibition Task EEG from baseline to 2-months post-treatment. Metric: EEG spectral (theta) power Brier et al. (2010). Frontal theta and alpha power and coherence changes are modulated by semantic complexity in Go/NoGo tasks. International Journal of Psychophysiology, 78, 215-224.
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Inhibition Task EEG Event-Related Potential (N2/P3) [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on the Semantic Inhibition Task EEG from baseline to 1-week post-treatment. Metric: EEG N2/P3 event-related potential amplitude Brier et al. (2010). Frontal theta and alpha power and coherence changes are modulated by semantic complexity in Go/NoGo tasks. International Journal of Psychophysiology, 78, 215-224.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Inhibition Task EEG Event-Related Potential (N2/P3) [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on the Semantic Inhibition Task EEG from baseline to 2-months post-treatment. Metric: EEG N2/P3 event-related potential amplitude Brier et al. (2010). Frontal theta and alpha power and coherence changes are modulated by semantic complexity in Go/NoGo tasks. International Journal of Psychophysiology, 78, 215-224.
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval EEG spectral power [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on the Semantic Object Retrieval EEG from baseline to 1-week post-treatment. Metric: EEG spectral (theta) power Ferree et al. (2009). Space-time-frequency analysis of EEG data using within-subject statistical tests followed by sequential PCA. NeuroImage, 45, 109-121.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval EEG spectral power [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on the Semantic Object Retrieval EEG from baseline to 2-months post-treatment. Metric: EEG event-related potential amplitude Ferree et al. (2009). Space-time-frequency analysis of EEG data using within-subject statistical tests followed by sequential PCA. NeuroImage, 45, 109-121.
Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval EEG event-related potential [Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
Evaluation of treatment group differences in change on the Semantic Object Retrieval EEG from baseline to 1-week post-treatment. Metric: EEG late-onset (750 ms) event-related potential Brier et al. (2008). Event-related potentials in semantic memory retrieval. Journal of the International Neuropsychological Society, 14, 815-822.
Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval EEG event-related potential [Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Evaluation of treatment group differences in change on the Semantic Object Retrieval EEG from baseline to 2-months post-treatment. Metric: EEG late-onset (750 ms) event-related potential Brier et al. (2008). Event-related potentials in semantic memory retrieval. Journal of the International Neuropsychological Society, 14, 815-822.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed with relapsing-remitting multiple sclerosis (RRMS) with a memory retrieval deficit based on neuropsychological testing criteria and the last relapse being at least 6 months prior to enrollment. RRMS consists of fluctuating periods of worsening symptoms and recovery. Must be fluent in speaking and reading English.

Exclusion Criteria:

Eligible MS patients will be free of significant medical issues or substance abuse. Exclusion criteria are a relapse or acute MS exacerbation or a course of steroids in the two months preceding the testing. Participants using benzodiazepines must have been on a stable dose for at least two months. Before enrollment, aspects of the study protocol will be reviewed with each participant and informed written consent will be obtained.

Exclusion criteria include: a potentially confounding psychological or neurological disorder, including, dementia of any type, epilepsy or other seizure disorders; severe traumatic brain injury (based on the Ohio Stated TBI Identification Method); brain tumor; present drug abuse; stroke; blood vessel abnormalities in the brain; Parkinson's disease; or Huntington's disease. Participants being seen in the PIs clinics will assess these issues as a part of the standard clinical assessment. However, all potential participants also will complete a self-reported history during the assessment process for the study to determine to further assess and document whether exclusion criteria are present.

Additionally, exclusion criteria include inability to give informed consent; cranial implants or skull defects that affect tDCS administration; and use of medications that interact with or potentially interact with tDCS effects, including, anti-convulsants, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole, or citalopram

Patients that are on stimulants (dextroamphetamine/amphetamine) or modafinil/armodafinil can be considered for inclusion in the study if they agree to end use prior to HD tDCS treatment in Phase 1 and Phase 2 (2 days prior for stimulants; 3 days prior for modafinil/armodafinil) followed by reinstitution if desired after the final treatment. Additionally, we will delay doing immediate testing following the 10th session for 3 or more days if they decide to resume taking any of these medications after the 10th session.

Additionally, non-English speakers will be excluded because not all of the screening forms, questionnaires, and tests are available in languages other than English.