Cognitive Training and tDCS for Children With FASD

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT03361293
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.3
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

This is a randomized placebo-controlled trial of cognitive training with transcranial direct current stimulation (tDCS) for children and adolescents (ages 10 - 16 years) with prenatal alcohol exposure (PAE).

Condition or Disease	Intervention/Treatment	Phase
Fetal Alcohol Spectrum Disorders	Device: Active tDCS; Behavioral: Cognitive training; Device: Sham tDCS	N/A

Detailed Description

Prenatal alcohol exposure (PAE) has profound detrimental effects on brain development and, as a result, has permanent consequences for cognition, learning, and behavior. Individuals with Fetal Alcohol Spectrum Disorders (FASD) commonly have a range of neurocognitive impairments that directly lead to practical problems with learning, attention, working memory, task planning/execution, and decision making, among other areas of functioning. Despite the profound public health burden posed by FASD, there have been very few treatment studies in this population. This study will examine the effects of a cognitive remediation training augmented with tDCS in children and adolescents with PAE. Functional magnetic resonance imaging will be collected to provide preliminary data of brain circuitry changes created by this intervention. The study involves a baseline visit with cognitive testing, MRI, 5 sessions of tDCS (including the baseline visit), and a 6th visit for cognitive testing and MRI. All sessions will be completed within a 28 to 56 day time window.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 1:1 randomized allocation to active tDCS or placebo (sham tDCS).1:1 randomized allocation to active tDCS or placebo (sham tDCS).
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Participants and families will be blinded. The principal investigator will be blinded. The research staff member coordinating the visit will be blinded. The care provider is not involved in the research and is, therefore, blinded.
• Primary Purpose: Treatment
• Official Title: Neuromodulation Augmented Cognitive Remediation to Improve Executive Dysfunction in Fetal Alcohol Spectrum Disorder (FASD)
• Actual Study Start Date: Nov 20, 2017
• Actual Primary Completion Date: Jan 30, 2020
• Actual Study Completion Date: Jan 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cognitive Training and Active tDCS 5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).	Device: Active tDCS; Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode); Behavioral: Cognitive training; BrainHQ Computerized cognitive training
Sham Comparator: Cognitive Training and Sham tDCS 5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation).	Behavioral: Cognitive training; BrainHQ Computerized cognitive training; Device: Sham tDCS; Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)

Outcome Measures

Primary Outcome Measures

1. BrainHQ Learning Rate [Learning rate will be computed over 5 sessions of tDCS spanning 28 to 56 days; Each of the 5 tDCS sessions are 46 minutes long. The divided attention task is administered at the end of each tDCS session.]

   Participants completed a Divided Attention Task during 5 sessions of tDCS. Unit of measure: milliseconds Meaning: lowest threshold reached across trials / fastest reaction time Direction: lower values represent better performance

Secondary Outcome Measures

1. Change in D-KEFS Verbal Fluency - Letter [D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)]

   The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.

2. Change in D-KEFS Verbal Fluency - Category [D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)]

   The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.

3. Change in D-KEFS Trail-making - Numbers [D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)]

   The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.

4. Change in D-KEFS Trail-making - Letters [D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)]

   The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.

5. Change in D-KEFS Trail-making - Combined [D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)]

   The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.

6. Delis Rating of Executive Functioning (D-REF) [D-REF will be administered at baseline and at the final visit (28 to 56 days after baseline). NOTE that baseline scores are listed previously in the appropriate section]

   The Delis Rating of Executive Functioning (D-REF) contains 60 items rated by the parent to measure the child's executive functioning compared to age-peers. Results are calculated as T-scores, which have a mean of 50 and a standard deviation of 10. Here, we present the scores at study completion (visit 5), post-intervention. Greater values reflect greater executive functioning impairment.

7. Change in Flanker Inhibitory Control and Attention Task [NIH Toolbox will be administered at baseline and at the final visit (28 to 56 days after baseline)]

   The Flanker Inhibitory Control and Attention Task from the NIH Toolbox measure inhibitory control and attention. Task performance is in T-scores based on correct items and errors (mean of 50 and a standard deviation of 10). Here, we present difference scores between session 1 (baseline) T-score and 5 (completion) T-score. Greater values represents more change. Positive values represent improvement; negative values represent decline in performance.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Documented heavy prenatal alcohol exposure (self-report, social service records, or adoption records) and meeting criteria for an associated FASD diagnosis (FAS, partial FAS, or ARND).

• An available parent or legal guardian capable of giving informed consent

Exclusion Criteria:

• Substance abuse in the participant

• Neurological condition or other developmental disorder

• Serious psychiatric disorder known to affect brain functioning and cognitive performance

• Birthweight < 1500 grams

• MRI contraindication

• tDCS contraindication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55454

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: Jeffrey Wozniak, Ph.D., University of Minnesota

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 2, 2017
• Informed Consent Form - Sep 24, 2018

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03361293
• Other Study ID Numbers: PSYCH-2017-26075
• First Posted: Dec 4, 2017
• Last Update Posted: Mar 17, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Fetal Alcohol Spectrum Disorders

Study Results

Participant Flow

Arm/Group Title	Cognitive Training and Active tDCS	Cognitive Training and Sham tDCS
Arm/Group Description	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Period Title: Overall Study
STARTED	20	24
COMPLETED	19	19
NOT COMPLETED	1	5

Baseline Characteristics

Arm/Group Title	Cognitive Training and Active tDCS	Cognitive Training and Sham tDCS	Total
Arm/Group Description	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)	Total of all reporting groups
Overall Participants	19	19	38
Age (Count of Participants)
<=18 years	19 100%	19 100%	38 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	7 36.8%	9 47.4%	16 42.1%
Male	12 63.2%	10 52.6%	22 57.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 5.3%	1 2.6%
Native Hawaiian or Other Pacific Islander	1 5.3%	3 15.8%	4 10.5%
Black or African American	2 10.5%	2 10.5%	4 10.5%
White	9 47.4%	11 57.9%	20 52.6%
More than one race	6 31.6%	2 10.5%	8 21.1%
Unknown or Not Reported	1 5.3%	0 0%	1 2.6%
Region of Enrollment (participants) [Number]
United States	19 100%	19 100%	38 100%
Delis Rating of Executive Functioning (D-REF) (t-score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [t-score]	69.9 (9.0)	76.3 (11.7)	72.4 (10.8)

Outcome Measures

1. Primary Outcome

Title	BrainHQ Learning Rate
Description	Participants completed a Divided Attention Task during 5 sessions of tDCS. Unit of measure: milliseconds Meaning: lowest threshold reached across trials / fastest reaction time Direction: lower values represent better performance
Time Frame	Learning rate will be computed over 5 sessions of tDCS spanning 28 to 56 days; Each of the 5 tDCS sessions are 46 minutes long. The divided attention task is administered at the end of each tDCS session.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Training and Active tDCS	Cognitive Training and Sham tDCS
Arm/Group Description	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Measure Participants	19	19
Mean (Standard Deviation) [milliseconds]	867.6 (244.1)	861.7 (264.2)

2. Secondary Outcome

Title	Change in D-KEFS Verbal Fluency - Letter
Description	The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.
Time Frame	D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Training and Active tDCS	Cognitive Training and Sham tDCS
Arm/Group Description	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Measure Participants	19	19
Mean (Standard Deviation) [score on a scale]	-0.11 (2.05)	-0.05 (1.68)

3. Secondary Outcome

Title	Change in D-KEFS Verbal Fluency - Category
Description	The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.
Time Frame	D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Training and Active tDCS	Cognitive Training and Sham tDCS
Arm/Group Description	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Measure Participants	19	19
Mean (Standard Deviation) [score on a scale]	-3.68 (3.93)	-3.42 (3.37)

4. Secondary Outcome

Title	Change in D-KEFS Trail-making - Numbers
Description	The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.
Time Frame	D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Training and Active tDCS	Cognitive Training and Sham tDCS
Arm/Group Description	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Measure Participants	19	19
Mean (Standard Deviation) [score on a scale]	1.11 (3.2)	1.37 (3.2)

5. Secondary Outcome

Title	Change in D-KEFS Trail-making - Letters
Description	The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.
Time Frame	D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Training and Active tDCS	Cognitive Training and Sham tDCS
Arm/Group Description	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Measure Participants	19	19
Mean (Standard Deviation) [score on a scale]	1.05 (3.29)	-2.95 (3.73)

6. Secondary Outcome

Title	Change in D-KEFS Trail-making - Combined
Description	The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.
Time Frame	D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Training and Active tDCS	Cognitive Training and Sham tDCS
Arm/Group Description	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Measure Participants	19	19
Mean (Standard Deviation) [score on a scale]	-1.16 (6.24)	-2.05 (6.18)

7. Secondary Outcome

Title	Delis Rating of Executive Functioning (D-REF)
Description	The Delis Rating of Executive Functioning (D-REF) contains 60 items rated by the parent to measure the child's executive functioning compared to age-peers. Results are calculated as T-scores, which have a mean of 50 and a standard deviation of 10. Here, we present the scores at study completion (visit 5), post-intervention. Greater values reflect greater executive functioning impairment.
Time Frame	D-REF will be administered at baseline and at the final visit (28 to 56 days after baseline). NOTE that baseline scores are listed previously in the appropriate section

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Training and Active tDCS	Cognitive Training and Sham tDCS
Arm/Group Description	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Measure Participants	19	19
Mean (Standard Deviation) [t-score]	70.1 (11.9)	73.2 (9.5)

8. Secondary Outcome

Title	Change in Flanker Inhibitory Control and Attention Task
Description	The Flanker Inhibitory Control and Attention Task from the NIH Toolbox measure inhibitory control and attention. Task performance is in T-scores based on correct items and errors (mean of 50 and a standard deviation of 10). Here, we present difference scores between session 1 (baseline) T-score and 5 (completion) T-score. Greater values represents more change. Positive values represent improvement; negative values represent decline in performance.
Time Frame	NIH Toolbox will be administered at baseline and at the final visit (28 to 56 days after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Training and Active tDCS	Cognitive Training and Sham tDCS
Arm/Group Description	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Measure Participants	19	19
Mean (Standard Deviation) [t-score]	2.05 (8.1)	3.52 (8.92)

Adverse Events

Time Frame	56 days
Arm/Group Title	Cognitive Training and Active tDCS		Cognitive Training and Sham tDCS
Arm/Group Description	5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions). Active tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode) Cognitive training: BrainHQ Computerized cognitive training		5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation). Cognitive training: BrainHQ Computerized cognitive training Sham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
All Cause Mortality
	Cognitive Training and Active tDCS		Cognitive Training and Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)
Serious Adverse Events
	Cognitive Training and Active tDCS		Cognitive Training and Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		00/19 (0%)
Other (Not Including Serious) Adverse Events
	Cognitive Training and Active tDCS		Cognitive Training and Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/19 (100%)		19/19 (100%)
Ear and labyrinth disorders
Change in hearing	1/19 (5.3%)	1	0/19 (0%)	0
Balance problem	1/19 (5.3%)	1	2/19 (10.5%)	2
Gastrointestinal disorders
Nausea	2/19 (10.5%)	8	0/19 (0%)	0
General disorders
Headache	5/19 (26.3%)	9	4/19 (21.1%)	4
Sleepiness	12/19 (63.2%)	31	12/19 (63.2%)	38
Difficulty paying attention	7/19 (36.8%)	10	5/19 (26.3%)	7
Unusual feelings, attitudes, emotions	2/19 (10.5%)	2	2/19 (10.5%)	2
Tooth pain	1/19 (5.3%)	2	0/19 (0%)	0
Dizziness	1/19 (5.3%)	3	0/19 (0%)	0
Anxiety	2/19 (10.5%)	7	1/19 (5.3%)	1
Forgetfullness	3/19 (15.8%)	3	3/19 (15.8%)	3
Musculoskeletal and connective tissue disorders
Neck pain	2/19 (10.5%)	5	0/19 (0%)	0
Twitching / muscle movement	0/19 (0%)	0	1/19 (5.3%)	1
Nervous system disorders
Change in dominant hand function	1/19 (5.3%)	1	0/19 (0%)	0
Skin and subcutaneous tissue disorders
Scalp discomfort	8/19 (42.1%)	19	7/19 (36.8%)	11
Tingling	6/19 (31.6%)	13	6/19 (31.6%)	6
Itchiness	8/19 (42.1%)	16	10/19 (52.6%)	13

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.