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Trial Outcomes & Findings for Non-Invasive Brain Stimulation and Substance Use (NCT NCT03122587)

NCT ID: NCT03122587

Last Updated: 2020-03-06

Results Overview

The Computerized Paced Auditory Serial Addition Task (PASAT-C) is a psychological distress-inducing task. Numbers are presented sequentially on a computer screen and participants are asked to add the currently presented number to the previously presented number before the next number is presented. Participants select the answer using a computer mouse on a number pad displayed on the computer screen below the presented numbers. The speed of the number presentations is individually titrated in order to account for some individual differences in cognitive capacity, but not to secure equal performance among individuals. Incorrect or delayed responses are met with an aversive explosion sound. Distress tolerance is the latency to task termination (i.e., time until quit in minutes).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

From Session 1 to Session 2, up to 6 days

Results posted on

2020-03-06

Participant Flow

Participant milestones

Participant milestones
Measure
Active Sham Stimulation (Session 1 and Session 2)
Active sham transcranial alternating current stimulation: Active sham (placebo)
Active Sham (Session 1) and tACS at 10 Hz (Session 2)
Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 10 Hz during Session 2 Transcranial Alternating Current Stimulation at 10 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity
Active Sham (Session 1) and tACS at 40 Hz (Session 2)
Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 40 Hz during Session 2 Transcranial Alternating Current Stimulation at 40 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity
Overall Study
STARTED
13
12
13
Overall Study
COMPLETED
11
10
12
Overall Study
NOT COMPLETED
2
2
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non-Invasive Brain Stimulation and Substance Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active Sham Stimulation (Session 1 and Session 2)
n=13 Participants
Active sham transcranial alternating current stimulation: Active sham (placebo)
Active Sham (Session 1) and tACS at 10 Hz (Session 2)
n=12 Participants
Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 10 Hz during Session 2 Transcranial Alternating Current Stimulation at 10 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity
Active Sham (Session 1) and tACS at 40 Hz (Session 2)
n=13 Participants
Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 40 Hz during Session 2 Transcranial Alternating Current Stimulation at 40 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity
Total
n=38 Participants
Total of all reporting groups
Age, Continuous
43.5 years
STANDARD_DEVIATION 6.5 • n=5 Participants
43.3 years
STANDARD_DEVIATION 9.5 • n=7 Participants
42.9 years
STANDARD_DEVIATION 7.8 • n=5 Participants
43.2 years
STANDARD_DEVIATION 7.7 • n=4 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
13 Participants
n=4 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
9 Participants
n=7 Participants
8 Participants
n=5 Participants
25 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
11 Participants
n=4 Participants
Race (NIH/OMB)
White
7 Participants
n=5 Participants
8 Participants
n=7 Participants
7 Participants
n=5 Participants
22 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
5 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Region of Enrollment
United States
13 Participants
n=5 Participants
12 Participants
n=7 Participants
13 Participants
n=5 Participants
38 Participants
n=4 Participants

PRIMARY outcome

Timeframe: From Session 1 to Session 2, up to 6 days

Population: 3 participants did not have data due to impedance issues, behavioral noncompliance, and technology error

The Computerized Paced Auditory Serial Addition Task (PASAT-C) is a psychological distress-inducing task. Numbers are presented sequentially on a computer screen and participants are asked to add the currently presented number to the previously presented number before the next number is presented. Participants select the answer using a computer mouse on a number pad displayed on the computer screen below the presented numbers. The speed of the number presentations is individually titrated in order to account for some individual differences in cognitive capacity, but not to secure equal performance among individuals. Incorrect or delayed responses are met with an aversive explosion sound. Distress tolerance is the latency to task termination (i.e., time until quit in minutes).

Outcome measures

Outcome measures
Measure
Active Sham Stimulation (Session 1 and Session 2)
n=10 Participants
Active sham transcranial alternating current stimulation: Active sham (placebo)
Active Sham (Session 1) and tACS at 10 Hz (Session 2)
n=10 Participants
Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 10 Hz during Session 2 Transcranial Alternating Current Stimulation at 10 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity
Active Sham (Session 1) and tACS at 40 Hz (Session 2)
n=10 Participants
Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 40 Hz during Session 2 Transcranial Alternating Current Stimulation at 40 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity
Change in Distress Tolerance (Mean Latency to Quit the PASAT-C)
11.2 minutes
Standard Deviation 5.5
9.8 minutes
Standard Deviation 6.4
9.4 minutes
Standard Deviation 6.2

PRIMARY outcome

Timeframe: From Session 1 to Session 2, up to 6 days

Population: 3 participants did not have data due to impedance issues, behavioral noncompliance, and technology error

During the computerized Go/No-Go task, participants view a serial stream of pictures and are instructed to continuously press a button on the computer keyboard, but inhibit responses when stimuli are presented consecutively. Inhibitory control will be calculated as d-prime \[z(hit rate) - z(false alarm rate)\]. Each z-score of 0 is equal to the mean of the reference population, with a standard deviation of 1. Positive d-prime values indicate more inhibitory control, and negative values indicate less inhibitory control.

Outcome measures

Outcome measures
Measure
Active Sham Stimulation (Session 1 and Session 2)
n=10 Participants
Active sham transcranial alternating current stimulation: Active sham (placebo)
Active Sham (Session 1) and tACS at 10 Hz (Session 2)
n=10 Participants
Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 10 Hz during Session 2 Transcranial Alternating Current Stimulation at 10 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity
Active Sham (Session 1) and tACS at 40 Hz (Session 2)
n=10 Participants
Active Sham during Session 1 and Transcranial Alternating Current Stimulation at 40 Hz during Session 2 Transcranial Alternating Current Stimulation at 40 Hz: Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity
Change in Inhibitory Control (Mean D-prime on the Go/No-Go)
-0.6 z-score
Standard Deviation 2.0
0.9 z-score
Standard Deviation 1.7
-0.3 z-score
Standard Deviation 1.9

Adverse Events

Active Sham Stimulation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Active Sham (Session 1) and tACS at 10 Hz (Session 2)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Active Sham (Session 1) and tACS at 40 Hz (Session 2)

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

Stacey Daughters, PhD

University of North Carolina at Chapel Hill

Phone: 9199629924

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place