NCT05404360Unknown不适用
A Prospective Double Blind Randomized Controlled Trial to Evaluate the Long Term Efficacy and Durability of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Brainsway
- 入组人数
- 124
- 主要终点
- Yale Brown Obsessive Compulsive Scale (YBOCS)
研究概览
简要总结
A Prospective Double Blind Randomized Controlled Trial to Evaluate the Long Term Efficacy and Durability of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects
详细描述
The study is a randomized, double-blind, multi-center trial comparing active Deep TMS treatment to sham treatment over the course of the trial. The treatment phase will consist of 44 treatments over thirteen weeks. The acute treatment phase will consist five daily treatments over the course of six weeks, followed by twice weekly continuation treatments for seven weeks. Responders will be eligible to enter the durability phase. For assessment of durability, responders will be assessed quarterly for up to one year from the end of the treatment phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The treatment administrator, all study personnel and patients will be blinded to the treatment being administrated.
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •Males and females, 18-88 years of age
- •Diagnosed as suffering from OCD according to the DSM-V.
- •Subjects with a YBOCS score of >
- •If on SRI, patient must be maintained on current dosages (with or without additional antidepressant or psychotropic augmentation for treatment of OCD), at a stable therapeutic dosage for at least 2 months prior to study entry and for the duration of the trial.
- •If in CBT, must be in the maintenance stage (i.e., not receiving active training in exposure and response prevention, which is the core component of this treatment). CBT can be with teletherapy but must be for a minimum of ten sessions with a symptom checklist, hierarchy, with exposure and response prevention therapy.
- •Have negative or justified responses by the investigator to all questions listed on the Transcranial Magnetic Stimulation Safety Screening questionnaire (TASS).
- •According to the treating physician the subject is compliant with taking medication, if applicable.
- •Subject is capable and willing to provide informed consent and assent.
- •Willing and able to adhere to the treatment schedule.
- •Must own a smartphone.
- •All comorbid diagnoses have been stable for 3 months and anticipated to be stable for the 3 months treatment duration.
排除标准
- •Subjects diagnosed as suffering from any other Axis I diagnosis as the primary diagnosis.
- •Comorbid, secondary psychiatric diagnoses are unstable and are likely to require changes in therapeutic regimens even if OCD improves.
- •Present suicidal risk as assessed by the investigator using the Columbia Suicide Severity Rating Scale, brief mental status exam and psychiatric interview or a history of attempted suicide in the past year.
- •History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT and febrile seizures in infancy).
- •Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure, or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes.
- •History of head injury necessitating cranial surgery or prolonged coma.
- •History of any ferromagnetic of conductive material in the head including the eyes and ears (outside the mouth).
- •Known history of any metallic particles in the eye, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes).
- •History of significant hearing loss.
- •Subjects with significant neurological disorder or insult including, but not limited to
- •Any condition likely to be associated with increased intracranial pressure
- •Space occupying brain lesion
- •History of cerebrovascular accident
- •Transient ischemic attack within two years
- •Cerebral aneurysm
- •Multiple sclerosis
- •Substance use disorder within the past 6 months (except nicotine and caffeine).
- •Currently participating in another therapeutic clinical study.
- •Suffer from an unstable physical, systemic and metabolic disorder such as unstable blood pressure, unstable blood sugar, or acute, unstable cardiac disease.
- •Subject on high doses of antidepressant or psychotropic medications, which are known to lower the seizure threshold. Subject is currently on Clomipramine.
- •Significant possibility of death within eighteen months of baseline.
- •Planned surgeries that will interrupt the study schedule within eighteen months of baseline
- •Treatment with any TMS in the past year.
- •Women who are breast-feeding.
- •Women who are pregnant or with suspected pregnancy.
- •Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale (YBOCS)
时间窗: 13 weeks
Change in YBOCS scores from baseline to the end of thirteen weeks between the active Deep TMS and Sham treatment groups. Scores on the YBOCS range from 0 (no Symptoms) to 40 (Extreme Symptoms).
次要结局
未报告次要终点
研究者
相似试验
撤回
4 期
Placebo-controlled Trial With Nasonex for Nasal Obstruction Secondary to Adenoids Hypertrophy in Children (P04367)(TERMINATED)Nasal ObstructionAdenoids HypertrophyAdenoidectomyNCT00553891Organon and Co
已完成
不适用
The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV InfectionHIV InfectionsNCT00002290Glaxo Wellcome
已完成
1 期
A Randomized, Controlled, Double-blind Clinical Trial of Surinam Cherry Dentifrice With Anti-gingivitis PropertiesGingivitisNCT02648139Federal University of Paraíba50
已完成
4 期
Determining the Prognostic Value of Continuous Intrathecal InfusionLumbar Post-Laminectomy SyndromeChronic Low Back PainVertebral Compression FractureFailed Back Surgery SyndromeNCT03523000University Hospitals Cleveland Medical Center36
Unknown
2 期
Study to Evaluate Efficacy and Safety of NDS-446 in Men With Lower Urinary Tract Symptoms (LUTS)Lower Urinary Tract SymptomsNCT02808013Naturex-Dbs116