Trial Outcomes & Findings for Effect of Electrical Stimulation (DC Polarization) to the Brain on Memory (NCT NCT00471107)

Results Overview

The Wechsler Memory Scale (WMS-III) is a neuropsychological test designed to measure different memory functions. The WMS-III Word Lists is a measure of verbal learning ability. The examiner reads a list of 12 semantically unrelated words and the subject immediately recalls as many words as possible. For this study, the primary outcome is a measure of verbal recall performance at 24 hours following presentation of the words under three conditions, i.e., anodal tDCS, cathodal tDCS, and sham. Scores may range from 0 (no words recalled) to 12 (all words recalled).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

45 participants

Primary outcome timeframe

24 hours

Results posted on

2016-03-24

Participant Flow

Healthy subjects were recruited through the NIH Clinical Research Volunteer Program

Nothing to report

Participant milestones

Participant milestones
Measure	Anodal TDCS Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.	Cathodal TDCS Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.	Sham TDCS Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
Overall Study STARTED	15	15	15
Overall Study COMPLETED	12	14	12
Overall Study NOT COMPLETED	3	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Anodal TDCS Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.	Cathodal TDCS Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.	Sham TDCS Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
Overall Study Technical problems/data loss	3	1	3

Baseline Characteristics

Effect of Electrical Stimulation (DC Polarization) to the Brain on Memory

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anodal TDCS n=12 Participants Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.	Cathodal TDCS n=14 Participants Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.	Sham TDCS n=12 Participants Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.	Total n=38 Participants Total of all reporting groups
Age, Continuous	26.5 years STANDARD_DEVIATION 8.06 • n=5 Participants	32.4 years STANDARD_DEVIATION 14.05 • n=7 Participants	32.5 years STANDARD_DEVIATION 11.29 • n=5 Participants	30.57 years STANDARD_DEVIATION 11.60 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	19 Participants n=4 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: All subjects in this group for whom data were obtained were analyzed

The Wechsler Memory Scale (WMS-III) is a neuropsychological test designed to measure different memory functions. The WMS-III Word Lists is a measure of verbal learning ability. The examiner reads a list of 12 semantically unrelated words and the subject immediately recalls as many words as possible. For this study, the primary outcome is a measure of verbal recall performance at 24 hours following presentation of the words under three conditions, i.e., anodal tDCS, cathodal tDCS, and sham. Scores may range from 0 (no words recalled) to 12 (all words recalled).

Outcome measures

Outcome measures
Measure	Left Prefrontal Anodal TDCS n=12 Participants Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.	Left Prefrontal Cathodal TDCS n=14 Participants Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.	Sham TDCS n=12 Participants Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
Verbal Memory	8.625 Words recalled Standard Deviation 1.768	9 Words recalled Standard Deviation 1.604	8 Words recalled Standard Deviation 2.828

Adverse Events

Anodal TDCS

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Cathodal TDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham TDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Anodal TDCS n=12 participants at risk Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.	Cathodal TDCS n=14 participants at risk Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.	Sham TDCS n=12 participants at risk Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
Skin and subcutaneous tissue disorders Burn	8.3% 1/12 • Number of events 1	0.00% 0/14	0.00% 0/12

Other adverse events

Adverse event data not reported

Additional Information

Eric Wassermann

NIH/NINDS

Phone: 301-496-0151

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place