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

NCT07032428 | Not Yet Recruiting DMC

• 1 other identifier: Magnetic Tides Inc.
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anhedonia; Major Depressive Disorder (MDD)

Keywords

kTMP; NIBS; anhedonia; Major Depressive Disorder; Cortical Excitability; Plasticity; Neuroscience; reward network; kilohertz Transcranial Magnetic Perturbation

Outcome Measures

Primary Outcomes (2)

• Ventral striatal BOLD response during reward anticipation

  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.

  2 months

• The relationship between the level of ventral striatal engagement and clinical scores of anhedonia

  For each patient, we will obtain the Snaith-Hamilton Pleasure Scale (SHAPS) scores and carry out a multiple regression analysis

  2 months

Secondary Outcomes (11)

• 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

Study Arms (2)

Active kTMP

EXPERIMENTAL

Participants received 8 V/m of active stimulation

Device: A new non-invasive brain stimulation tool

Sham kTMP

SHAM COMPARATOR

Participants received 0.0 V/m of sham stimulation

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

Interventions

A new non-invasive brain stimulation tool DEVICE

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.

Active kTMP

A new non-invasive brain stimulation tool with sham setting selected DEVICE

This device will counterbalance the active kTMP conditions

Sham kTMP

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Magnetic Tides: lead
• University of California, San Francisco: collaborator

Related Links

• ELife paper accepted: Kilohertz Transcranial Magnetic Perturbation (kTMP): A New Non-invasive Method to Modulate Cortical Excitability

MeSH Terms

Conditions

Anhedonia; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Ludovica Labruna

CONTACT

510-423-7125; participate@magnetictides.com

Christina Merrick

CONTACT

participate@magnetictides.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: June 24, 2025
• Study Start: July 15, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share