Major Depressive DisorderRESONATENCT07594483
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
A study testing Motif XCS System in people with Major Depressive Disorder, run by Motif Neurotech, Inc. at 3 sites in United States.
Trial summary
The objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the Motif eXternally powered Cortical Stimulation (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
- 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
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2026to Dec 2027
- 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 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 Diagnostic and Statistical Manual of Mental Disorders (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
Show all 25Show fewer
- 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 transcranial magnetic stimulation (TMS) for treatment of MDD
- Is planning to receive any other neuromodulation therapy 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 Columbia-Suicide Severity Rating Scale [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 Digitally Programmable Over-Brain Therapeutic (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
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ted Meehan contact
United States3 sites, 3 recruiting
- Recruiting
Emory Healthcare
Atlanta, Georgia, 30322
Sinead Quinn, 404-727-9228, scquinn@emory.edu
- Recruiting
Brain Health Consultants and TMS Center
Houston, Texas, 77046
Holly Lee, (713) 489-5000, hzl@brainhealthconsultants.com
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Karin Nielsen, 319-384-6521, karin-nielsen@uiowa.edu
About this study
The objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the Motif eXternally powered Cortical Stimulation (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
- 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 dorsolateral prefrontal cortex (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 posted18 May 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 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 DisorderStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Motif Neurotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Responsible party
- Sponsor
- Investigators
- Ted Meehan, Study director, Bright Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594483
- Sponsor's protocol ID
- TP-27
- Acronym
- RESONATE
- Status last verified
- Sep 2026
- First submitted
- 8 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
- ClinicalTrials.gov ID
- NCT07594483
- Acronym / sponsor ID
- RESONATE / TP-27
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Treatment-resistant depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Motif Neurotech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 May 2026 (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 objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the Motif eXternally powered Cortical Stimulation (XCS) System when used as indicated for treatment-resistant depression (TRD).
Detailed description
The Motif XCS System study is a prospective, multi-center, single-arm, open-label early feasibility study (EFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motif XCS System | Experimental | Device: Motif XCS System |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a diagnosis of unipolar non-psychotic Major Depressive Disorder (MDD) and is currently experiencing a major depressive episode (MDE) as defined by Diagnostic and Statistical Manual of Mental Disorders (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
Key exclusion criteria (25 listed)
- 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
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 |
|---|---|---|
| Motif XCS SystemThe 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 dorsolateral prefrontal cortex (DLPFC), without penetrating the dura. | Device | Motif XCS System |
Primary outcome
Incidence of device and/or procedure-related adverse events (AEs)
Time frame: During procedure to 12 months follow-up
2 secondary outcomes
Change in score on clinical outcome measures of treatment-resistant depression (Montgomery-Åsberg Depression Rating Scale [MADRS])
Time frame: After treatment to 12 months follow-up
The incidence of stimulation-induced side effects
Time frame: After treatment to 12 months follow-up
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 21 Oct 2026.
- Related InfoLink 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.
Ted Meehan contact
Ted Meehan study director
Bright Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motif XCS System in people with Major Depressive Disorder, run by Motif Neurotech, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Brandon Thio (201-381-1534, support@motifneuro.tech), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of device and/or procedure-related adverse events (AEs) (time frame: During procedure to 12 months follow-up). 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 21 Oct 2026.