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Not yet recruiting NCT07032428

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

No phase Interventional Anhedonia Major Depressive Disorder (MDD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A new non-invasive brain stimulation tool, A new non-invasive brain stimulation tool with sham setting selected.
Who it may be relevant to
Registry conditions: Anhedonia, Major Depressive Disorder (MDD). Basic parameters: 21 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

  • Device 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.
  • Device A new non-invasive brain stimulation tool with sham setting selected
    This device will counterbalance the active kTMP conditions

Primary outcome measures

  • Ventral striatal BOLD response during reward anticipation [Time frame: 2 months]
  • The relationship between the level of ventral striatal engagement and clinical scores of anhedonia [Time frame: 2 months]
Secondary outcome measures (11)
  • Changes in scores of the Snaith-Hamilton Pleasure Scale (SHAPS). [Time frame: 6 months]
  • The response bias in the Probabilistic Reward Task (PRT). [Time frame: 6 months]
  • The motivation to pursue reward in the Effort Expenditure for Rewards Task (EEfRT). [Time frame: 6 months]
  • Scores in the Visual Analog Scale of Anhedonia (VAS). [Time frame: 6 months]
  • Scores in the Temporal Experience of Pleasure Scale (TEPS). [Time frame: 6 months]
  • Scores in the Hamilton Rating Scale for Depression (HAM-D). [Time frame: 6 months]
  • Scores in the Hamilton Rating Scale for Anxiety (HAM-A). [Time frame: 6 months]
  • Scores in The Cognitive and Physical Functioning Questionnaire [Time frame: 6 months]
  • Scores in The Columbia Suicide Severity Rating Scale (CSSRS) [Time frame: 6 months]
  • Scores in The Clinical Global Impression - Severity (CGI-S) [Time frame: 6 months]
  • Scores in The Clinical Global Impression - Improvement (CGI-I) [Time frame: 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07032428 · Magnetic Tides Inc.

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗