N/A
N=8
Cerebellar rTMS for the Treatment of Schizophrenic Patients
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01072617 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Adverse Events — 1 event
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial magnetic stimulation via MagPro x100 device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
1 | — |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) - Positive Subscale |
17.13; 17; 16.25 | — |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) - Negative Subscale |
23.75; 19.75; 19.88 | — |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) - General Subscale |
41.38; 39.13; 37 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age between 18-65 years
- Diagnosis of schizophrenia according to DSM-IV criteria(by a board-certified psychiatrist)
Exclusion Criteria
- Prior neurosurgical procedures
- Any history of seizure
- Previous head injury
- Contraindication to TMS:
- Implanted pacemaker
- Medication pump
- Vagal stimulator
- Deep brain stimulator
- Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding
- Signs of increased intracranial pressure
- 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
Data sourced from ClinicalTrials.gov (NCT01072617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.