N/A
N=17
Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01551979 ↗Enrolled (actual)
17
Serious AEs
5.9%
Results posted
Jun 2017
Primary outcome: Primary: Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subscale — -2.4; -1.857; -5.889; -3.667 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Repetitive Transcranial Magnetic Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subscale |
-2.4; -1.857; -5.889; -3.667; -5; -3 | — |
| PRIMARY Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Negative Subscale |
-1; -1.571; -3.889; -1.667; -3.5; -0.2 | — |
| PRIMARY Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) General Subscale |
-3.1; -2.714; -8.222; -2; -7.375; 0 | — |
| PRIMARY Change From Baseline on the Clinical Global Impression (CGI) Severity of Illness |
-0.3; -0.286; -0.4; -0.5; -0.5; -0.2 | — |
| PRIMARY Clinical Global Impression (CGI) Global Improvement |
3.6; 3.429; 3.3; 4; 3.375; 3.8 | — |
| SECONDARY Change From Baseline on the Calgary Depression Scale for Schizophrenia |
-2.6; -1.167; -2.7; -1.833; -2.25; 0.8 | — |
Summary
The aim of this study is to look at the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a therapeutic intervention for patients with schizophrenia. The primary outcome is improvement in negative symptoms related to schizophrenia. The investigators are focusing on negative symptoms given their greater resistance to pharmacological and other established therapies. If the investigators trial were to show beneficial effects, its clinical significance would be great.
Eligibility Criteria
Inclusion Criteria
- Age between 18-65 years
- Diagnosis of schizophrenia according to DSM-IV criteria (Diagnostic and Statistical Manual) by a board-certified psychiatrist
Exclusion Criteria
- Preexisting or progressive neurological disorders
- Prior neurological procedures
- Previous head injury
- Change in antipsychotic medication during the last 4 weeks
- Been an inpatient in a psychiatry clinic within the last month
- Any other axis 1 diagnosis
- Patients may not be actively enrolled in a separate intervention study
- Patients unable to undergo a brain MRI
- Any unstable medical condition
- History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform\_ EEG, or family history of treatment resistant epilepsy
- Possible pregnancy. All female participants of child bearing age are required to have a pregnancy test.
- Any metal in the brain, skull, or elsewhere unless approved by the responsible MD
- Any medical devices (ie. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
- Substance abuse (alcohol, amphetamines, cocaine, MDMA [methylenedioxymethamphetamine], ecstasy, PCP [phencyclidine], Angle dust) or dependence within the past six months
- No medication is an absolute exclusion from TMS. Medications will be reviewed by the responsible MD and a decision about inclusion will be made based on the following: the patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other CNS (central nervous system) active drugs (the published TMS guidelines review of medications to be considered with TMS)
Data sourced from ClinicalTrials.gov (NCT01551979). 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.