Summary

Eligibility
for people ages 18-65 (full criteria)
Dates
study started
completion around

Description

Summary

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.

Details

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.

Keywords

Anhedonia in Major Depressive Disorder, kTMP, NIBS, anhedonia, Major Depressive Disorder, Cortical Excitability, Plasticity, Neuroscience, reward network, kilohertz Transcranial Magnetic Perturbation, Depressive Disorder, Depression, A new non-invasive brain stimulation tool

Eligibility

You can join if…

Open to people ages 18-65

(1) Patients 21-65 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.

You CAN'T join if...

(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.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Magnetic Tides
Links
ELife paper accepted: Kilohertz Transcranial Magnetic Perturbation (kTMP): A New Non-invasive Method to Modulate Cortical Excitability
ID
NCT07032428
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated