Major Depressive Disorder (MDD)RESONATE-MNCT07684794
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium - Maintenance
A study testing Motif XCS System in people with Major Depressive Disorder (MDD), run by Motif Neurotech, Inc..
Trial summary
The objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the Motif XCS System when used as indicated for treatment-resistant depression (TRD). Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Motif XCS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2026to 31 Dec 2027
- Phase
- Interventional
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 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a diagnosis of unipolar non-psychotic Major Depressive Disorder (MDD) and is currently experiencing a major depressive episode (MDE) as defined by DSM-5
- Has a screening Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥20
- Has not had a sustained response to 2 or more adequately dosed antidepressant treatments from at least 2 different antidepressant treatment classes in at least one episode of major depressive disorder, according to the Antidepressant Treatment History Form (ATHF)
- Is willing and able to provide written informed consent
- Is 22-85 years of age
- Is willing and able to comply with the protocol, including follow-up visits
- Has been on a stable psychiatric treatment regimen for 30 days before the study screening MADRS and is willing to maintain a stable psychiatric treatment regimen through the Week 4 follow-up visit
Who cannot join
- Has a cranial implant (with the exception of dental implants), neurostimulator, implanted medication pump, spinal cord stimulator, or pacemaker/implantable cardioverter-defibrillator
- Has knowledge of planned magnetic resonance imaging (MRIs) in the next 12 months, after implant
- Is unable to undergo imaging with computed tomography (CT), magnetic resonance imaging (MRI), diffusion tensor imaging (DTI), or functional magnetic resonance imaging (fMRI)
- In the opinion of the investigator, the implant and therapy pose an unacceptable surgical or medical risk to the patient
- Is currently taking blood thinners and cannot be taken off blood thinners
- Has taken ketamine or esketamine in the past 30 days or is planning on taking ketamine or esketamine before the 4-week follow-up visit
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- Has taken hallucinogenic or dissociative medications in the past 30 days or is planning on taking hallucinogenic or dissociative medications for the treatment of mood or anxiety disorders before the 4-week follow-up visit
- Has a history of bipolar disorder
- Has a history of schizophrenia, schizoaffective disorder, or other psychotic disorder
- Has psychotic features in the current depressive episode
- Has a chronic and clinically significant neurological disorder (epilepsy, dementia, delirium, amnestic disorder, brain tumor), or neuroimaging findings that would potentially impact the efficacy of treatment (e.g., extensive white matter disease, demyelinating lesions, atrophy, brain tumor)
- Currently taking medication that would alter the seizure threshold, increasing potential seizure risks
- Has a history of brain injury that resulted in current cognitive impairment
- Has a history of bony disorders that impact the safe and effective use of the device as well as device implantation
- Has a history of skin disorders that impact the safe and effective use of the device as well as device implantation
- Has failed all attempts to achieve at least 50% reduction in depressive symptoms after completion of approved treatment courses of electroconvulsive therapy (ECT) or TMS for treatment of MDD
- Is planning to receive any other neuromodulation therapy (e.g., ECT, TMS, tDCS, tACS, DBS, VNS, or focused ultrasound) during the study
- Meets the DSM-5 criteria for alcohol use disorder or other substance use disorder (not including tobacco/nicotine) within 12 months prior to study enrollment or, in the opinion of the investigator, is using illicit drugs recreationally or therapeutically which could impact the safety or effectiveness of the therapy
- Female who is pregnant at the time of inclusion, or planning to become pregnant during the duration of the study, or not willing to use an effective method of birth control
- Has a life expectancy less than 12 months
- In the opinion of the investigator, is considered to be acutely suicidal (e.g., Type 4 or 5 on the C-SSRS)
- In the investigator's opinion, any known comorbidity that would complicate the assessment of safety or prevent participation in follow-up visits
- Before implantation of the Motif DOT Implant, subjects must continue to meet all study eligibility criteria. Subjects must also meet the following additional criteria:
- Psychiatric treatment regimen has remained stable
- Has skull thickness ≥5.5 mm and ≤15.5 mm over the implant target
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the Motif XCS System when used as indicated for treatment-resistant depression (TRD).
Read the detailed description
The Motif XCS System study is a prospective, multi-center, single-arm, open-label early feasibility study (EFS).
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Motif XCS System
- Keywords
- Depression, treatment resistant depression
- Medical subject headings
- Depressive Disorder, Major, Depression, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motif XCS SystemDevice
The Motif XCS System is a programmable device that delivers stimulation through surface electrodes implanted in a burr hole in the skull, positioned over the left DLPFC, without penetrating the dura.
| Study group | Role | What they receive |
|---|---|---|
| Motif XCS System | Experimental | Not described Receives: Device: Motif XCS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device and/or procedure-related adverse events (AEs)
Measured: During procedure to 12 months follow-up
Secondary outcomes (2)
Change in score on clinical outcome measures of treatment-resistant depression (Montgomery-Åsberg Depression Rating Scale [MADRS])
MADRS Scale: 0-60 (higher score indicates worse outcome)
Measured: After treatment to 12 months follow-up
The incidence of stimulation-induced side effects
Measured: After treatment to 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start10 Aug 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Motif Neurotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Esther Elliott, Study director, Alithia Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684794
- Sponsor's protocol ID
- TP-31
- Acronym
- RESONATE-M
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No