An interventional study of A new non-invasive brain stimulation tool and A new non-invasive brain stimulation tool with sham setting selected in Anhedonia and Major Depressive Disorder (MDD), sponsored by Magnetic Tides. Not yet recruiting. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Magnetic Tides · Not applicable, Interventional, and Treatment
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.
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.
119 studies on the registry are indexed under Anhedonia; 44 are open to participants now.
This study's planned enrollment of 104 is above the median of 70 across 99 interventional studies indexed under Anhedonia.
Browse Anhedonia studies →Magnetic Tides is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Participants received 8 V/m of active stimulation
Device: A new non-invasive brain stimulation tool
Participants received 0.0 V/m of sham stimulation
Device: A new non-invasive brain stimulation tool with sham setting selected
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.
This device will counterbalance the active kTMP conditions
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
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
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
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
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
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
Scores in the Temporal Experience of Pleasure Scale (TEPS).
The TEPS is an 18-item self-report measurement of anticipatory and consummatory components of anhedonia which consists of a series of statements that must be rated according to how accurate they are for the individual.
Time frame: 6 months
Scores in the Hamilton Rating Scale for Depression (HAM-D).
The HAM-D 17-item version will be included in exploratory analysis to provide confirmatory support for changes in depression severity with treatment.
Time frame: 6 months
Scores in the Hamilton Rating Scale for Anxiety (HAM-A).
The HAM-A is a rating scale designed to measure the severity of anxiety symptoms.
Time frame: 6 months
Scores in The Cognitive and Physical Functioning Questionnaire
The Cognitive and Physical Functioning Questionnaire (CPFQ) is a 7-item self-report instrument was intended to be a brief scale for measuring cognitive and executive dysfunction in patients with mood and anxiety disorders.
Time frame: 6 months
Scores in The Columbia Suicide Severity Rating Scale (CSSRS)
A suicide risk assessment tool that supports suicide risk assessment through a series of simple, plain-language questions that anyone can ask.
Time frame: 6 months
Scores in The Clinical Global Impression - Severity (CGI-S)
The CGI-S is a widely administered clinician rated global measure of subject overall illness severity.
Time frame: 6 months
Scores in The Clinical Global Impression - Improvement (CGI-I)
The CGI-I is a widely administered clinician rated global measure of the degree of improvement from the initial assessment in subject overall illness severity.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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