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 volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
A new non-invasive brain stimulation tool
DevicekTMP 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
DeviceThis device will counterbalance the active kTMP conditions
Treatment groups
Trial outcomes
Primary outcomes
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.
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
Secondary outcomes
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.
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.
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.
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.
Locations
Sponsors and contacts
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Magnetic Tides
Lead sponsor
University of California, San Francisco
Collaborator
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