Trial Outcomes & Findings for Treating Refractory Schizophrenia With rTMS (NCT NCT02242578)
NCT ID: NCT02242578
Last Updated: 2021-04-12
Results Overview
Participants will receive baseline and post-treatment protocol neuropsychiatric measures. These rating scales are accepted and standardized.
TERMINATED
NA
2 participants
Participants will be followed for an expected average of 5 weeks
2021-04-12
Participant Flow
Participant milestones
| Measure |
Active
Active rTMS stimulation (1 Hz rTMS, 10 Hz rTMS)
1 Hz rTMS: About 1,000 stimulation pulses over 20 min
10 Hz rTMS: About 1,000 stimulation pulses over 20 min
|
Placebo
Sham rTMS stimulation (1 Hz rTMS, 10 Hz rTMS)
1 Hz rTMS: About 1,000 stimulation pulses over 20 min
10 Hz rTMS: About 1,000 stimulation pulses over 20 min
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating Refractory Schizophrenia With rTMS
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Participants will be followed for an expected average of 5 weeksPopulation: Study was terminated (that is, stopped prematurely) and no data were collected for one or more Outcome Measures.
Participants will receive baseline and post-treatment protocol neuropsychiatric measures. These rating scales are accepted and standardized.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Participants will be followed for an expected average of 5 weeksPopulation: Study was terminated (that is, stopped prematurely) and no data were collected for one or more Outcome Measures.
Electroencephalographic (EEG) recordings and evaluations: Patients will undergo 19-channel EEG recordings before, and immediately after the end of the 5-day rTMS treatment. Patients will be kept awake during this procedure to control for the effects of sleep on EEG. Each EEG recording will be performed by employing scalp electrodes placed according to the International 10-20 system. Data will be analyzed for changes in the spectral characteristics of the EEG, most importantly in delta and beta frequency bands.
Outcome measures
Outcome data not reported
Adverse Events
Active
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Robert J Buchanan, MD
The University of Texas at Austin
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place