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

Not Yet RecruitingNA

Sponsor: Magnetic Tides

Conditions: Anhedonia, Major Depressive Disorder (MDD)

Interventions: A new non-invasive brain stimulation tool, A new non-invasive brain stimulation tool with sham setting selected

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.

Eligibility overview

Sex: ALL

Age: 21 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.