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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorMagnetic Tides

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

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

    Device

    This device will counterbalance the active kTMP conditions

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Active kTMPExperimental treatment 1 intervention
Group B: Sham kTMPSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 months
2

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

Time frame
2 months

Secondary outcomes

1

Changes in scores of the Snaith-Hamilton Pleasure Scale (SHAPS).

The Snaith-Hamilton Pleasure Scale (SHAPS) is a well-validated 14-item questionnaire used to assess anhedonia. It asks participants to agree or disagree with statements of hedonic response in pleasurable situations.

Time frame
6 months
2

The response bias in the Probabilistic Reward Task (PRT).

This task is designed to assess the propensity to modulate behavior as a function of reinforcement history and has been found to reflect reward-related function.

Time frame
6 months
3

The motivation to pursue reward in the Effort Expenditure for Rewards Task (EEfRT).

The primary outcome measure in EEfRT is the proportion of high-effort, high-reward choices a participant makes with respect to low-effort, low-reward option, which indicates their willingness to expend effort to attain a larger reward.

Time frame
6 months
4

Scores in the Visual Analog Scale of Anhedonia (VAS).

The Visual Analog Scale (VAS)-Anhedonia is a standard VAS assessment of anhedonia severity which provides a global anhedonia indicator.

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Magnetic Tides

Lead sponsor

University of California, San Francisco

Collaborator

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