HtDCS: A Novel Neurorehabilitation Approach for Cognitive Aging With HIV

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT02391311
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Duration (Months): 10.1
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

The goal of this study is to conduct a small, self-contained project to test the hypothesis that tDCS will augment SOP cognitive remediation therapy (CRT) in older HIV+ adults. The investigators will randomly assign 60 HIV+ older adults (i.e., ≥ 50 years old) to 10-hours in either a SOP CRT + sham tDCS condition (n=30) or SOP CRT + active tDCS condition (n=30) and examine neurocognitive functioning at baseline and 6 weeks post-intervention. Hypothesis 1: The SOP CRT + active tDCS condition will show larger proximal (i.e., SOP) gains than the SOP CRT + sham tDCS condition. Hypothesis 2: The active tDCS condition will demonstrate generalization to secondary neurocognitive domains compared to the sham tDCS condition.

Condition or Disease	Intervention/Treatment	Phase
HIV; Aging	Device: transcranial direct current stimulation (tDCS)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Speed of Processing Training With Transcranial Direct Current Stimulation in Older HIV+ Adults (HtDCS)
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sham tDCS + Cognitive Remediation Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.	Device: transcranial direct current stimulation (tDCS); tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.; Other Names: transcranial electrical stimulation (tES)
Experimental: Active tDCS + Cognitive Remediation Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.	Device: transcranial direct current stimulation (tDCS); tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.; Other Names: transcranial electrical stimulation (tES)

Outcome Measures

Primary Outcome Measures

1. Change in the Processing of Speed [baseline, 6 week posttest]

   Computerized and paper & pencil processing speed measures were used to evaluate this outcome. The Letter and Pattern Comparison Tasks are traditional paper and pencil (SOP) measures. Specifically, they assess perceptual speed. In Letter Comparison subjects are shown three sets of 32 pairs of letters containing 3, 6, or 9 segments. The participants are instructed to decide whether the patterns between the pairs are the same or different within each set, with a time limit of 20 sec per set. Pattern Comparison also presents three sets of 32 pairs of patterns with 3, 6, or 9 line segments. Similarly, participants are instructed to decide whether the patterns are the same or different within the 20 sec time limit. For each measure, the total score is the number of correct answers from all three sets. Larger scores indicate better reasoning and cognitive functioning. In this study scores from Letter and Pattern Comparison were combined for a total Letter/Pattern Score.

Secondary Outcome Measures

1. Change in Driving Simulator Performance [baseline, 6 week posttest]

   Driving Simulator Performance: Center lane crossings (a count of how many times an individual crosses the centerline during the entire simulator drive). A difference score was taken between time 2 and time 1 and compared between treatment groups (sham condition and tDCS condition). A negative difference score indicates that fewer center line crossings were made at time 2 than time 1, while positive difference scores indicate the opposite direction, and scores of 0 represent no change.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• HIV+

• Aged 50 and older

• Patient at University HIV/AIDS Clinic

Exclusion Criteria:

• Not homeless

• Not blind or deaf

• No significant neuromedical issues (e.g., schizophrenia, bipolar disorder, stroke, epilepsy or history of seizures)

• No pacemaker or other biomedical devices or metal implants

• No untreated hypertension

• Not undergoing chemo or radiation

• No head injury with LOC greater than 30 mins

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB 1917 Clinic	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Pariya L Fazeli, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pariya L. Fazeli, PhD, Principal investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT02391311
• Other Study ID Numbers: K99AG048762
• First Posted: Mar 18, 2015
• Last Update Posted: May 15, 2017
• Last Verified: May 1, 2017

• Keywords provided by Pariya L. Fazeli, PhD, Principal investigator, University of Alabama at Birmingham: tDCS; Cognitive remediation therapy

Study Results

Participant Flow

Recruitment Details	Protocol Open to Accrual: March 2015, Primary Completion Date: January 2016 and Study Completion Date: January 2016. Recruitment location: University of Alabama at Birmingham.
Pre-assignment Detail	48 subjects were screened/eligible, however the phone screen did not include consenting. 42 showed up for baseline testing and were consented, thus 42 subjects were enrolled. 42 were randomized immediately after baseline testing, however 5 were either lost to followup or deemed ineligible after baseline testing. See below for further breakdown.

Arm/Group Title	Sham tDCS + Cognitive Remediation	Active tDCS + Cognitive Remediation
Arm/Group Description	Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition. transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.	Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition. transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.
Period Title: Overall Study
STARTED	21	21
COMPLETED	18	19
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Sham tDCS + Cognitive Remediation	Active tDCS + Cognitive Remediation	Total
Arm/Group Description	Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition. transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.	Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition. transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.	Total of all reporting groups
Overall Participants	16	17	33
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	55.63	56	55.82
Sex: Female, Male (Count of Participants)
Female	5 31.3%	6 35.3%	11 33.3%
Male	11 68.8%	11 64.7%	22 66.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	14 87.5%	14 82.4%	28 84.8%
White	2 12.5%	3 17.6%	5 15.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	16 100%	17 100%	33 100%

Outcome Measures

1. Primary Outcome

Title	Change in the Processing of Speed
Description	Computerized and paper & pencil processing speed measures were used to evaluate this outcome. The Letter and Pattern Comparison Tasks are traditional paper and pencil (SOP) measures. Specifically, they assess perceptual speed. In Letter Comparison subjects are shown three sets of 32 pairs of letters containing 3, 6, or 9 segments. The participants are instructed to decide whether the patterns between the pairs are the same or different within each set, with a time limit of 20 sec per set. Pattern Comparison also presents three sets of 32 pairs of patterns with 3, 6, or 9 line segments. Similarly, participants are instructed to decide whether the patterns are the same or different within the 20 sec time limit. For each measure, the total score is the number of correct answers from all three sets. Larger scores indicate better reasoning and cognitive functioning. In this study scores from Letter and Pattern Comparison were combined for a total Letter/Pattern Score.
Time Frame	baseline, 6 week posttest

Outcome Measure Data

Analysis Population Description

n=33 subjects were included in final analyses. Of the 37 that completed the study, 4 were deemed ineligible after they had completed the study due to confirmation with medical records they had conditions that may affect neurocognition (stroke and schizophrenia) although they self reported on the screen they did not have these conditions.

Arm/Group Title	Sham tDCS + Cognitive Remediation	Active tDCS + Cognitive Remediation
Arm/Group Description	Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition. transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.	Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition. transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.
Measure Participants	16	17
Mean (Full Range) [units on a scale]	2.63	6.06

2. Secondary Outcome

Title	Change in Driving Simulator Performance
Description	Driving Simulator Performance: Center lane crossings (a count of how many times an individual crosses the centerline during the entire simulator drive). A difference score was taken between time 2 and time 1 and compared between treatment groups (sham condition and tDCS condition). A negative difference score indicates that fewer center line crossings were made at time 2 than time 1, while positive difference scores indicate the opposite direction, and scores of 0 represent no change.
Time Frame	baseline, 6 week posttest

Outcome Measure Data

Analysis Population Description

While n=33 was the final sample used for the primary outcome analyses, n=30 was used for the secondary outcome as 3 subjects did not have available simulator data.

Arm/Group Title	Sham tDCS + Cognitive Remediation	Active tDCS + Cognitive Remediation
Arm/Group Description	Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition. transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.	Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition. transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.
Measure Participants	15	15
Mean (95% Confidence Interval) [Times crossing center lane]	1.867	-1.800

Adverse Events

Time Frame	Functioning at baseline and 6 weeks post-intervention
Arm/Group Title	Sham tDCS + Cognitive Remediation		Active tDCS + Cognitive Remediation
Arm/Group Description	Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition. transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.		Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition. transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.
All Cause Mortality
	Sham tDCS + Cognitive Remediation		Active tDCS + Cognitive Remediation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/19 (0%)
Serious Adverse Events
	Sham tDCS + Cognitive Remediation		Active tDCS + Cognitive Remediation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Sham tDCS + Cognitive Remediation		Active tDCS + Cognitive Remediation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.