Efficacy of kTMP, a Novel Non-invasive Brain Stimulation Method, for the Treatment of Anhedonia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 主要终点
- Ventral striatal BOLD response during reward anticipation
研究概览
简要总结
The goal of this proposal is to provide a first assessment of the efficacy of our innovative non-invasive brain stimulation system, kTMP, in the treatment of anhedonia in MDD.
详细描述
The goal of this clinical trial is to to test and validate a novel, first-in-class, non-invasive approach to engage the brain reward circuitry for treating anhedonia, a core symptom of Major Depressive Disorder (MDD). We've developed a kilohertz Transcranial Magnetic Perturbation (kTMP) device that non-invasively modulates neural activity without patient discomfort. The trial will assess the proof-of-mechanism for kTMP's efficacy in improving anhedonia in MDD patients.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Patients 21-80 years of age with clinically significant anhedonia, as defined by a SHAPS score of at least 20, and (2) Meet DSM-VTR diagnostic criteria for Major Depressive Disorder.
排除标准
- •(1) Reason to anticipate possible hospitalization during the course of the study; (2) Current/history of a psychotic disorder, current manic or mixed episode, meeting the DSM-VTR criteria for bipolar disorder, post-traumatic stress disorder, schizophrenia, at screening, autism spectrum disorders, or mental retardation; (3) Meet DSM-VTR criteria for a substance use disorder within the last year; (4) Current suicidal ideation, suicidal ideation with intent, plan or attempt within the last year, or are considered at significant risk for suicide during the study; (5) Use of any drugs/medications that may interfere/interact with the expected outcomes of the study within 5 half-lives of study participation (see Human Subject section for details); (6) History of seizure; (7) Intracranial expansive process; (8) Pacemaker or any metal implants in head/neck region; (9) Pregnancy; (10) Uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease, severe alcohol or drug abuse within the past year; (11) Contraindications for non-invasive brain stimulation or magnetic resonance imaging procedures; (12) Any other condition that in the opinion of the investigator would preclude participation in the study.
研究组 & 干预措施
Sham kTMP
Participants received 0.0 V/m of sham stimulation
干预措施: A new non-invasive brain stimulation tool with sham setting selected (Device)
Active kTMP
Participants received 8 V/m of active stimulation
干预措施: A new non-invasive brain stimulation tool (Device)
结局指标
主要结局
Ventral striatal BOLD response during reward anticipation
时间窗: 2 months
To assess ventral striatal activation during reward anticipation, patients will participate in a Monetary Incentive Delay (MID) task while in an MRI scanner. We will measure the change in BOLD response during reward anticipation trials, comparing active and sham kTMP and the parametric effect of kTMP on the BOLD response.
The relationship between the level of ventral striatal engagement and clinical scores of anhedonia
时间窗: 2 months
For each patient, we will obtain the Snaith-Hamilton Pleasure Scale (SHAPS) scores and carry out a multiple regression analysis
次要结局
- Scores in The Cognitive and Physical Functioning Questionnaire(6 months)
- Changes in scores of the Snaith-Hamilton Pleasure Scale (SHAPS).(6 months)
- The response bias in the Probabilistic Reward Task (PRT).(6 months)
- The motivation to pursue reward in the Effort Expenditure for Rewards Task (EEfRT).(6 months)
- Scores in the Visual Analog Scale of Anhedonia (VAS).(6 months)
- Scores in the Temporal Experience of Pleasure Scale (TEPS).(6 months)
- Scores in the Hamilton Rating Scale for Depression (HAM-D).(6 months)
- Scores in the Hamilton Rating Scale for Anxiety (HAM-A).(6 months)
- Scores in The Columbia Suicide Severity Rating Scale (CSSRS)(6 months)
- Scores in The Clinical Global Impression - Severity (CGI-S)(6 months)
- Scores in The Clinical Global Impression - Improvement (CGI-I)(6 months)