Trial Outcomes & Findings for Repetitive TMS & Cognitive Training in Adults With Schizophrenia (NCT NCT03741751)
NCT ID: NCT03741751
Last Updated: 2026-03-10
Results Overview
Evaluate differences in neuropsychological functioning between active and sham rTMS groups using the Screen for Cognitive Impairment in Psychiatry (SCIP). Scores are reported as Z-scores standardized to age-adjusted normative data. A Z-score of 0 represents the population mean, and each unit reflects one standard deviation from that mean. Higher Z-scores indicate better cognitive performance. Scores are interpreted relative to normative expectations rather than a diagnostic threshold. Change scores represent the value at 2 weeks minus the baseline value.
TERMINATED
NA
12 participants
2 weeks
2026-03-10
Participant Flow
Participants were recruited from the St. Louis Metropolitan area.
Twelve participants provided informed consent; six were randomized and six were not assigned to an intervention.
Participant milestones
| Measure |
Active rTMS With Computerized Cognitive Training
Participants will receive 6 sessions of active rTMS followed by a computerized cognitive training session over 2 weeks.
|
Sham rTMS With Computerized Cognitive Training
Participants will receive 6 sessions of sham rTMS followed by a computerized cognitive training session over 2 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Repetitive TMS & Cognitive Training in Adults With Schizophrenia
Baseline characteristics by cohort
| Measure |
Active rTMS With Computerized Cognitive Training
n=3 Participants
Participants will receive 6 sessions of active rTMS followed by a computerized cognitive training session over 2 weeks.
|
Sham rTMS With Computerized Cognitive Training
n=3 Participants
Participants will receive 6 sessions of sham rTMS followed by a computerized cognitive training session over 2 weeks.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 1.73 • n=68 Participants
|
46 years
STANDARD_DEVIATION 19.68 • n=69 Participants
|
45 years
STANDARD_DEVIATION 12.54 • n=137 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
WHODAS Total Score
|
12.00 Score
STANDARD_DEVIATION 19.92 • n=68 Participants
|
50.67 Score
STANDARD_DEVIATION 42.85 • n=69 Participants
|
31.33 Score
STANDARD_DEVIATION 35.60 • n=137 Participants
|
PRIMARY outcome
Timeframe: 2 weeksEvaluate differences in neuropsychological functioning between active and sham rTMS groups using the Screen for Cognitive Impairment in Psychiatry (SCIP). Scores are reported as Z-scores standardized to age-adjusted normative data. A Z-score of 0 represents the population mean, and each unit reflects one standard deviation from that mean. Higher Z-scores indicate better cognitive performance. Scores are interpreted relative to normative expectations rather than a diagnostic threshold. Change scores represent the value at 2 weeks minus the baseline value.
Outcome measures
| Measure |
Active rTMS With Computerized Cognitive Training
n=3 Participants
Participants will receive 6 sessions of active rTMS followed by a computerized cognitive training session over 2 weeks.
|
Sham rTMS With Computerized Cognitive Training
n=3 Participants
Participants will receive 6 sessions of sham rTMS followed by a computerized cognitive training session over 2 weeks.
|
|---|---|---|
|
Difference in Groups on Neuropsychological Testing
|
1.89 Z-score
Standard Deviation 1.67
|
0.48 Z-score
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: 2 weeksDisability was measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), a standardized instrument assessing functional impairment across multiple domains of daily living. Total scores range from 0 to 100, with higher scores indicating greater disability. Change scores were calculated as the value at 2 weeks minus the baseline value.
Outcome measures
| Measure |
Active rTMS With Computerized Cognitive Training
n=3 Participants
Participants will receive 6 sessions of active rTMS followed by a computerized cognitive training session over 2 weeks.
|
Sham rTMS With Computerized Cognitive Training
n=3 Participants
Participants will receive 6 sessions of sham rTMS followed by a computerized cognitive training session over 2 weeks.
|
|---|---|---|
|
Change in WHODAS Total Score From Baseline to 2 Weeks
|
-1.33 WHODAS total score change
Standard Deviation 2.31
|
-10.33 WHODAS total score change
Standard Deviation 11.50
|
Adverse Events
Active rTMS With Computerized Cognitive Training
Sham rTMS With Computerized Cognitive Training
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active rTMS With Computerized Cognitive Training
n=3 participants at risk
Participants will receive 6 sessions of active rTMS followed by a computerized cognitive training session over 2 weeks.
|
Sham rTMS With Computerized Cognitive Training
n=3 participants at risk
Participants will receive 6 sessions of sham rTMS followed by a computerized cognitive training session over 2 weeks.
|
|---|---|---|
|
Nervous system disorders
headache
|
33.3%
1/3 • Number of events 1 • From enrollment until the end of participation, up to 2 weeks.
Adverse events were collected systematically at each study visit via participant self-report and clinician inquiry. Events were classified as serious or non-serious according to standard ClinicalTrials.gov definitions. Expected adverse events, including headache, were listed in the informed consent document.
|
0.00%
0/3 • From enrollment until the end of participation, up to 2 weeks.
Adverse events were collected systematically at each study visit via participant self-report and clinician inquiry. Events were classified as serious or non-serious according to standard ClinicalTrials.gov definitions. Expected adverse events, including headache, were listed in the informed consent document.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place