Trial Outcomes & Findings for Non-Invasive Direct Current Stimulation for Cognition in Schizophrenia (NCT NCT02739347)
NCT ID: NCT02739347
Last Updated: 2022-07-07
Results Overview
The investigators will assess cognitive control using the Preparing to Overcome Prepotency (POP) task. The accuracy mean differences between the high and low control conditions will be used as dependent measures. The study is powered at 0.8 to observe a post-pre treatment improvement in cognitive control with a substantial effect size (d=0.56) compared to sham stimulation with effects relatively stable measured 2 months after baseline. The hypothesized effect size will be d=0.60.
TERMINATED
NA
17 participants
Week 1
2022-07-07
Participant Flow
The reason we have fewer subjects randomized than enrolled is that some participants did not meet criteria to be randomized. These subjects were consented and completed many assessments, but were ultimately not randomized due to how they scored on some assessments. For instance, some participants MCCB score was too high to be randomized into the study.
The primary reasons for ineligibility were not taking any anti-psychotic medication, and positive drug screen. There were also many who did not even enter screening due to the assessment that they would highly likely not meet the threshold of requirement cognitive impairment (MATRICS score \< 40).
Participant milestones
| Measure |
Active Stimulation
Active stimulation group will receive 20 min of 2 mA direct current stimulation.
Active Trans-cranial direct-current stimulation: Active stimulation group will receive 20 min of 2 mA direct current stimulation.
|
Sham Stimulation
This will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms.
Sham Trans-cranial direct current stimulation: This will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
|
Overall Study
COMPLETED
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Active Stimulation
Active stimulation group will receive 20 min of 2 mA direct current stimulation.
Active Trans-cranial direct-current stimulation: Active stimulation group will receive 20 min of 2 mA direct current stimulation.
|
Sham Stimulation
This will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms.
Sham Trans-cranial direct current stimulation: This will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Non-Invasive Direct Current Stimulation for Cognition in Schizophrenia
Baseline characteristics by cohort
| Measure |
Active Stimulation
n=5 Participants
Active stimulation group will receive 20 min of 2 mA direct current stimulation.
Active Trans-cranial direct-current stimulation: Active stimulation group will receive 20 min of 2 mA direct current stimulation.
|
Sham Stimulation
n=7 Participants
This will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms.
Sham Trans-cranial direct current stimulation: This will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms.
|
Total
n=12 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
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
33 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
33 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 1Population: We have reported all available data.
The investigators will assess cognitive control using the Preparing to Overcome Prepotency (POP) task. The accuracy mean differences between the high and low control conditions will be used as dependent measures. The study is powered at 0.8 to observe a post-pre treatment improvement in cognitive control with a substantial effect size (d=0.56) compared to sham stimulation with effects relatively stable measured 2 months after baseline. The hypothesized effect size will be d=0.60.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 1Population: We have reported all available data.
The investigators will assess working memory using a working memory task. The accuracy mean differences between the high and low control conditions will be used as dependent measures. The study is powered at 0.8 to observe a post-pre treatment improvement in cognitive control with a substantial effect size (d=0.56) compared to sham stimulation with effects relatively stable measured 2 months after baseline. The hypothesized effect size will be d=0.60.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1Population: We have reported all available data.
A secondary outcome measure is the severity of negative symptoms as quantified by Scale for the Assessment of Negative Symptoms (SANS). This study is powered at 0.8 to observe a post-pre treatment improvement in negative symptoms with a moderate effect size (d=0.56) compared to sham stimulation with effects relatively stable measured 2 months after baseline. The hypothesized effect size will be d=0.60.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1Population: We have reported all available data.
A secondary outcome measure is the change over time in the severity of auditory hallucinations as assessed by the Auditory Hallucination Rating Scale (AHRS). In a study conducted using a similar montage and current strength (Brunelin et. al 2012), a reduction in auditory hallucinations with a substantial effect size (d=1.58) was observed in 30 patients with schizophrenia. However, as their study recruited only those patients with severe hallucinations while the current study does not have such an inclusion criterion. The investigators expect a more modest effect size of d=0.60.
Outcome measures
Outcome data not reported
Adverse Events
Active Stimulation
Sham Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Stimulation
n=5 participants at risk
Active stimulation group will receive 20 min of 2 mA direct current stimulation.
Active Trans-cranial direct-current stimulation: Active stimulation group will receive 20 min of 2 mA direct current stimulation.
|
Sham Stimulation
n=7 participants at risk
This will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms.
Sham Trans-cranial direct current stimulation: This will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Minor Burn
|
20.0%
1/5 • Number of events 1 • Two months.
|
0.00%
0/7 • Two months.
|
|
Psychiatric disorders
Cognitive Decline
|
0.00%
0/5 • Two months.
|
14.3%
1/7 • Number of events 1 • Two months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60