Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia
关键词
抽象
描述
This study builds on the results of a previous phase 1, single-site study in which we demonstrated the safety of image-guided theta burst stimulation (TBS) form of rTMS over the cerebellar vermis (Demirtas-Tatlidede et al., 2010) in eigh patients with schizophrenia.
The primary goal of the present study is to assess efficacy of iTBS to the cerebellar vermis on positive and negative symptoms of schizophrenia. A second, added goal is to investigate the mechanisms of the expected clinical improvement.
Schizophrenia is a leading cause of mental disability and current treatments still remain only partially successful for many patients. Our underlying hypothesis is that modulation of the cerebellar vermis may enhance activity of the neural systems that sub-serve cognition and emotion, reestablish the disturbed cerebellar regulation in schizophrenic patients, and produce clinical improvement.
日期
| 最后验证: | 02/28/2018 |
| 首次提交: | 02/29/2012 |
| 提交的预估入学人数: | 03/08/2012 |
| 首次发布: | 03/12/2012 |
| 上次提交的更新: | 03/13/2018 |
| 最近更新发布: | 04/11/2018 |
| 首次提交结果的日期: | 03/14/2017 |
| 首次提交质量检查结果的日期: | 04/30/2017 |
| 首次发布结果的日期: | 06/01/2017 |
| 实际学习开始日期: | 01/31/2012 |
| 预计主要完成日期: | 10/31/2015 |
| 预计完成日期: | 10/31/2015 |
状况或疾病
干预/治疗
Device: Repetitive Transcranial Magnetic Stimulation
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Active rTMS High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum. | |
| Sham Comparator: Sham rTMS Sham rTMS to the vermis (lobule VII) of the cerebellum. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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) |
结果
主要结果指标
1. Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subscale [Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment]
2. Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Negative Subscale [Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment]
3. Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) General Subscale [Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment]
4. Change From Baseline on the Clinical Global Impression (CGI) Severity of Illness [Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment]
5. Clinical Global Impression (CGI) Global Improvement [Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment]
次要成果指标
1. Change From Baseline on the Calgary Depression Scale for Schizophrenia [Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment]
