Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary aim of this protocol is to determine whether the use of repetitive transcranial magnetic stimulation (rTMS) over vermis of the cerebellum may be safe and therapeutically effective in patients with schizophrenia. Because this is the first evaluation of this treatment in this population, the focus of this study is safety.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety of rTMS in schizophrenia patients | Experimental | Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial magnetic stimulation via MagPro x100 device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 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. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Prior neurosurgical procedures
Any history of seizure
Previous head injury
Contraindication to TMS:
TENS unit and ventriculo-peritoneal shunt
Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
Advanced liver, kidney, cardiac, or pulmonary disease as defined clinically or a terminal medical diagnosis consistent with survival < 1 year
A history of significant alcohol or drug abuse in the prior six months
No focal cortical insult can be present, including tumor or vascular malformation
Patients may not be actively enrolled in a separate intervention study
Patients unable to undergo a brain MR:
a. claustrophobia refractory to anxiolytics ferromagnetic metal in the body such as a prosthetic heart valve, a pacemaker, or a brain aneurysm clip).
Change in antipsychotic medication during the last 4 weeks
Any emergency psychiatry department visit during the last 4 weeks
Been an inpatient in a psychiatry clinic within the last month
Any other axis I diagnosis
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alvaro Pascual-Leone, MD, PhD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events | 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. | Posted | Number | event | 3 weeks |
|
3 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High blood pressure | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alvaro Pascual-Leone | BIDMC | 617-667-0203 | apleone@bidmc.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline, 5 days (post-treatment), 1 week post treatment |
| Positive and Negative Syndrome Scale (PANSS) - Negative Subscale | 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. | Baseline, 5 days (post-treatment), 1 week post treatment |
| Positive and Negative Syndrome Scale (PANSS) - General Subscale | 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. | Baseline, 5 days (post-treatment), 1 week post treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | 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. | Posted | Mean | Standard Deviation | percentage of change | Baseline, 5 days (post-treatment), 1 week post treatment |
|
|
|
| Secondary | Positive and Negative Syndrome Scale (PANSS) - Negative Subscale | 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. | Posted | Mean | Standard Deviation | percentage of change | Baseline, 5 days (post-treatment), 1 week post treatment |
|
|
|
| Secondary | Positive and Negative Syndrome Scale (PANSS) - General Subscale | 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. | Posted | Mean | Standard Deviation | percentage of change | Baseline, 5 days (post-treatment), 1 week post treatment |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
Not provided
Not provided
|
|
|