Trial Outcomes & Findings for Bilateral Repetitive Transcranial Magnetic Stimulation for Auditory Hallucinations Results (NCT NCT04548622)

Results Overview

The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia.The PANSS positive symptoms hallucinication score has a range of 1-7. Higher scores indicate more severe positive symptoms in patients with schizophrenia.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

baseline to 4 weeks

Results posted on

2020-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	Non-randomized Bilateral rTMS Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus Magstim Rapid 2 system triggering Magstim Super Rapid system: Week 1 treatment includes rTMS for 5 sessions to both the left and right Wernicke's area (BA22) synchronous with rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 treatment includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, active rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-randomized Bilateral rTMS n=15 Participants Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus Magstim Rapid 2 system triggering Magstim Super Rapid system: Week 1 treatment includes rTMS for 5 sessions to both the left and right Wernicke's area (BA22) synchronous with rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 treatment includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, active rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption.
Age, Continuous	31 years STANDARD_DEVIATION 10 • n=15 Participants
Sex: Female, Male Female	7 Participants n=15 Participants
Sex: Female, Male Male	8 Participants n=15 Participants
Region of Enrollment United States	15 participants n=15 Participants

PRIMARY outcome

Timeframe: baseline to 4 weeks

The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia.The PANSS positive symptoms hallucinication score has a range of 1-7. Higher scores indicate more severe positive symptoms in patients with schizophrenia.

Outcome measures

Outcome measures
Measure	Non-randomized Bilateral rTMS n=15 Participants Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus Magstim Rapid 2 system triggering Magstim Super Rapid system: Week 1 treatment includes rTMS for 5 sessions to both the left and right Wernicke's area (BA22) synchronous with rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 treatment includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, active rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption.
PANSS Composite Positive Symptoms Hallucination Score Baseline	5.19 units on a scale Standard Deviation 0.85
PANSS Composite Positive Symptoms Hallucination Score 4 weeks	4.19 units on a scale Standard Deviation 1.07

PRIMARY outcome

Timeframe: baseline to 4 weeks

The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia.The PANSS negative scale has 7 Items, with a minimum score of 7 and a maximum score of 49. Higher scores indicate more severe negative symptoms in patients with schizophrenia.

Outcome measures

Outcome measures
Measure	Non-randomized Bilateral rTMS n=15 Participants Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus Magstim Rapid 2 system triggering Magstim Super Rapid system: Week 1 treatment includes rTMS for 5 sessions to both the left and right Wernicke's area (BA22) synchronous with rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 treatment includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, active rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption.
PANSS Composite Negative Symptom Scale Baseline	16.9 units on a scale Standard Deviation 5.22
PANSS Composite Negative Symptom Scale 4 weeks	12.53 units on a scale Standard Deviation 4.54

PRIMARY outcome

Timeframe: baseline to 4 weeks

The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia.The PANSS total score has a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms in patients with schizophrenia.

Outcome measures

Outcome measures
Measure	Non-randomized Bilateral rTMS n=15 Participants Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus Magstim Rapid 2 system triggering Magstim Super Rapid system: Week 1 treatment includes rTMS for 5 sessions to both the left and right Wernicke's area (BA22) synchronous with rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 treatment includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, active rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption.
PANSS Total Score Baseline	67.8 units on a scale Standard Deviation 17.9
PANSS Total Score 4 weeks	53.2 units on a scale Standard Deviation 14.9

Adverse Events

Non-randomized Bilateral rTMS

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

Dr. Philip R. Corlett PhD

Yale University Department of Psychiatry

Phone: (203) 974-7866

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place