Trial Outcomes & Findings for Modulation of Fear Extinction Processes Using Transcranial Electrical Stimulation (NCT NCT02723188)

Results Overview

GSR was measured throughout the task using 2 standard electrodes on the fingers. Measurement units were in micro-Siemens; scores were square-root-transformed (a common method in GSR studies). A higher level of GSR in response to stimuli is taken to reflect greater physiological fear response, and thus worse in the context of the relevance of the study conditions to the treatment of anxiety disorders. Scores were collected in response to presentation of the CS+ (the stimulus conditioned to be associated with an aversive outcome) and the CS- (the stimulus not conditioned to be associated with any outcome).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

During three-day experimental task

Results posted on

2017-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Sham Sham electrical stimulation Sham stimulation (1.5 milliampere,30 seconds)	DC (Direct Current) Direct current electrical stimulation DC stimulation (1.5 milliampere, 20 minutes)	AC (Alternating Current) Alternating current electrical stimulation AC stimulation (1.5 milliampere,1.5 Hertz frequency)
Overall Study STARTED	15	15	15
Overall Study COMPLETED	14	15	15
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sham Sham electrical stimulation Sham stimulation (1.5 milliampere,30 seconds)	DC (Direct Current) Direct current electrical stimulation DC stimulation (1.5 milliampere, 20 minutes)	AC (Alternating Current) Alternating current electrical stimulation AC stimulation (1.5 milliampere,1.5 Hertz frequency)
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

Modulation of Fear Extinction Processes Using Transcranial Electrical Stimulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham n=15 Participants Sham electrical stimulation Sham stimulation (1.5 milliampere,30 seconds)	DC: Direct Current n=15 Participants Direct current electrical stimulation DC stimulation (1.5 milliampere, 20 minutes)	AC: Alternating Current n=15 Participants Alternating current electrical stimulation AC stimulation (1.5 milliampere,1.5 Hertz frequency)	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	45 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	27 years STANDARD_DEVIATION 7 • n=5 Participants	23 years STANDARD_DEVIATION 3 • n=7 Participants	25 years STANDARD_DEVIATION 5 • n=5 Participants	25 years STANDARD_DEVIATION 6 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants
Region of Enrollment Israel	15 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	45 Participants n=4 Participants

PRIMARY outcome

Timeframe: During three-day experimental task

GSR was measured throughout the task using 2 standard electrodes on the fingers. Measurement units were in micro-Siemens; scores were square-root-transformed (a common method in GSR studies). A higher level of GSR in response to stimuli is taken to reflect greater physiological fear response, and thus worse in the context of the relevance of the study conditions to the treatment of anxiety disorders. Scores were collected in response to presentation of the CS+ (the stimulus conditioned to be associated with an aversive outcome) and the CS- (the stimulus not conditioned to be associated with any outcome).

Outcome measures

Outcome measures
Measure	Sham n=14 Participants Sham electrical stimulation Sham stimulation (1.5 milliampere,30 seconds)	DC: Direct Current n=15 Participants Direct current electrical stimulation DC stimulation (1.5 milliampere, 20 minutes)	AC: Alternating Current n=15 Participants Alternating current electrical stimulation AC stimulation (1.5 milliampere,1.5 Hertz frequency)
Galvanic Skin Response (GSR) CS (conditioned stimulus)+	.45 micro-Siemens Standard Deviation .38	.56 micro-Siemens Standard Deviation .57	.65 micro-Siemens Standard Deviation .46
Galvanic Skin Response (GSR) CS-	.23 micro-Siemens Standard Deviation .25	.54 micro-Siemens Standard Deviation .54	.24 micro-Siemens Standard Deviation .38

SECONDARY outcome

Timeframe: During three-day experimental task

Participants marked how fearful they are of stimuli used in the task on a single 10-point scale (1=not afraid, 10=extremely afraid). Higher scores therefore reflect greater fear and are worse in the context of treatment for anxiety disorders. Scores were collected in response to presentation of the CS+ (the stimulus conditioned to be associated with an aversive outcome) and the CS- (the stimulus not conditioned to be associated with any outcome).

Outcome measures

Outcome measures
Measure	Sham n=14 Participants Sham electrical stimulation Sham stimulation (1.5 milliampere,30 seconds)	DC: Direct Current n=15 Participants Direct current electrical stimulation DC stimulation (1.5 milliampere, 20 minutes)	AC: Alternating Current n=15 Participants Alternating current electrical stimulation AC stimulation (1.5 milliampere,1.5 Hertz frequency)
Self-reported Fear Rankings CS+	3.8 units on a scale Standard Deviation 2.5	4.7 units on a scale Standard Deviation 2.1	5.3 units on a scale Standard Deviation 2.5
Self-reported Fear Rankings CS-	3.2 units on a scale Standard Deviation 2.0	2.5 units on a scale Standard Deviation 1.2	2.7 units on a scale Standard Deviation 2.2

Adverse Events

Sham

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DC: Direct Current

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AC: Alternating Current

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yair Bar-Haim

Tel Aviv University

Phone: 97236406393

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place