AnhedoniakTMP AnhedoniaNCT07032428
Efficacy of kTMP, a Novel Non-invasive Brain Stimulation Method, for the Treatment of Anhedonia
A study testing A new non-invasive brain stimulation tool in people with Anhedonia and Major Depressive Disorder (MDD), run by Magnetic Tides.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Anhedonia, Major Depressive Disorder (MDD)
- What is being tested?
- A new non-invasive brain stimulation tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Christina Merrick contact
About this study
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.
Read the 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.
- Conditions
- Anhedonia, Major Depressive Disorder (MDD)
- Being tested
- A new non-invasive brain stimulation tool, A new non-invasive brain stimulation tool with sham setting selected
- Keywords
- kTMP, NIBS, anhedonia, Major Depressive Disorder, Cortical Excitability, Plasticity, Neuroscience, reward network, kilohertz Transcranial Magnetic Perturbation
- Medical subject headings
- Anhedonia, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A new non-invasive brain stimulation toolDevice
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 selectedDevice
This device will counterbalance the active kTMP conditions
| Study group | Role | What they receive |
|---|---|---|
| Active kTMP | Experimental | Participants received 8 V/m of active stimulation Receives: Device: A new non-invasive brain stimulation tool |
| Sham kTMP | Sham comparator | Participants received 0.0 V/m of sham stimulation Receives: Device: A new non-invasive brain stimulation tool with sham setting selected |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 2 months
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start15 Jul 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnhedoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Magnetic Tides
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032428
- Sponsor's protocol ID
- Magnetic Tides Inc.
- Acronym
- kTMP Anhedonia
- Status last verified
- Jul 2026
- First submitted
- 14 Jun 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of kTMP, a Novel Non-invasive Brain Stimulation Method, for the Treatment of Anhedonia
- ClinicalTrials.gov ID
- NCT07032428
- Acronym / sponsor ID
- kTMP Anhedonia / Magnetic Tides Inc.
- Conditions
- Anhedonia, Major Depressive Disorder (MDD)
- Keywords
- kTMP, NIBS, anhedonia, Major Depressive Disorder, Cortical Excitability, Plasticity, Neuroscience, reward network
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Magnetic TidesIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active kTMP | Experimental | Device: A new non-invasive brain stimulation toolParticipants received 8 V/m of active stimulation |
| Sham kTMP | Sham comparator | Device: A new non-invasive brain stimulation tool with sham setting selectedParticipants received 0.0 V/m of sham stimulation |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A new non-invasive brain stimulation toolkTMP 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 | Active kTMP |
| A new non-invasive brain stimulation tool with sham setting selectedThis device will counterbalance the active kTMP conditions | Device | Sham kTMP |
Primary outcome
Ventral striatal BOLD response during reward anticipation
Time frame: 2 months
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
Time frame: 2 months
For each patient, we will obtain the Snaith-Hamilton Pleasure Scale (SHAPS) scores and carry out a multiple regression analysis
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- ELife paper accepted: Kilohertz Transcranial Magnetic Perturbation (kTMP): A New Non-invasive Method to Modulate Cortical ExcitabilityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Merrick contact
Questions about this trial
What is this clinical trial studying?
A study testing A new non-invasive brain stimulation tool in people with Anhedonia and Major Depressive Disorder (MDD), run by Magnetic Tides.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ludovica Labruna (510-423-7125, participate@magnetictides.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventral striatal BOLD response during reward anticipation (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.