Efficacy of kTMP, a Novel Non-invasive Brain Stimulation Method, for the Treatment of Anhedonia

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство A new non-invasive brain stimulation tool
  kTMP is a magnetic induction method that delivers continuous kHz-frequency cortical electric fields (E-fields) which may be amplitude-modulated to potentially mimic electrical activity at endogenous frequencies which will be tested on anhedonia patients in this study.
• Устройство A new non-invasive brain stimulation tool with sham setting selected
  This device will counterbalance the active kTMP conditions

Первичные конечные точки

• Ventral striatal BOLD response during reward anticipation [Срок оценки: 2 months]
• The relationship between the level of ventral striatal engagement and clinical scores of anhedonia [Срок оценки: 2 months]

Вторичные конечные точки (11)

• Changes in scores of the Snaith-Hamilton Pleasure Scale (SHAPS). [Срок оценки: 6 months]
• The response bias in the Probabilistic Reward Task (PRT). [Срок оценки: 6 months]
• The motivation to pursue reward in the Effort Expenditure for Rewards Task (EEfRT). [Срок оценки: 6 months]
• Scores in the Visual Analog Scale of Anhedonia (VAS). [Срок оценки: 6 months]
• Scores in the Temporal Experience of Pleasure Scale (TEPS). [Срок оценки: 6 months]
• Scores in the Hamilton Rating Scale for Depression (HAM-D). [Срок оценки: 6 months]
• Scores in the Hamilton Rating Scale for Anxiety (HAM-A). [Срок оценки: 6 months]
• Scores in The Cognitive and Physical Functioning Questionnaire [Срок оценки: 6 months]
• Scores in The Columbia Suicide Severity Rating Scale (CSSRS) [Срок оценки: 6 months]
• Scores in The Clinical Global Impression - Severity (CGI-S) [Срок оценки: 6 months]
• Scores in The Clinical Global Impression - Improvement (CGI-I) [Срок оценки: 6 months]

Критерии участия

Inclusion Criteria: (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.

Exclusion Criteria:(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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07032428 · Magnetic Tides Inc.

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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