Trial Outcomes & Findings for Cerebellar rTMS for the Treatment of Schizophrenic Patients (NCT NCT01072617)

Results Overview

Adverse event collection at baseline, daily for 5 days during treatment, every other day by phone until the final assessment at week 1 follow up visit.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

3 weeks

Results posted on

2017-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Safety of rTMS in Schizophrenia Patients Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity. Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cerebellar rTMS for the Treatment of Schizophrenic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety of rTMS in Schizophrenia Patients n=8 Participants Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity. Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system.
Age, Continuous	41 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Adverse event collection at baseline, daily for 5 days during treatment, every other day by phone until the final assessment at week 1 follow up visit.

Outcome measures

Outcome measures
Measure	Safety of rTMS in Schizophrenia Patients n=8 Participants Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity. Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system.
Adverse Events	1 event

SECONDARY outcome

Timeframe: Baseline, 5 days (post-treatment), 1 week post treatment

Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.

Outcome measures

Outcome measures
Measure	Safety of rTMS in Schizophrenia Patients n=8 Participants Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity. Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system.
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Before treatment (baseline)	17.13 percentage of change Standard Deviation 5.69
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Last day of treatment (after 5 days of treatment)	17 percentage of change Standard Deviation 5.93
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale 1 week post treatment follow-up	16.25 percentage of change Standard Deviation 5.12

SECONDARY outcome

Timeframe: Baseline, 5 days (post-treatment), 1 week post treatment

Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.

Outcome measures

Outcome measures
Measure	Safety of rTMS in Schizophrenia Patients n=8 Participants Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity. Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system.
Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Before treatment (baseline)	23.75 percentage of change Standard Deviation 6.92
Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Last day of treatment (after 5 days of treatment)	19.75 percentage of change Standard Deviation 4.3
Positive and Negative Syndrome Scale (PANSS) - Negative Subscale 1 week post treatment follow-up	19.88 percentage of change Standard Deviation 5.82

SECONDARY outcome

Timeframe: Baseline, 5 days (post-treatment), 1 week post treatment

Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia. The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.

Outcome measures

Outcome measures
Measure	Safety of rTMS in Schizophrenia Patients n=8 Participants Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity. Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system.
Positive and Negative Syndrome Scale (PANSS) - General Subscale Before treatment (baseline)	41.38 percentage of change Standard Deviation 10.84
Positive and Negative Syndrome Scale (PANSS) - General Subscale Last day of treatment (after 5 days of treatment)	39.13 percentage of change Standard Deviation 11.81
Positive and Negative Syndrome Scale (PANSS) - General Subscale 1 week post treatment follow-up	37 percentage of change Standard Deviation 9.1

Adverse Events

Safety of rTMS in Schizophrenia Patients

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Safety of rTMS in Schizophrenia Patients n=8 participants at risk Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity. Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system.
Cardiac disorders High blood pressure	12.5% 1/8 • Number of events 1 • 3 weeks

Additional Information

Alvaro Pascual-Leone

BIDMC

Phone: 617-667-0203

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place