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Ecological Momentary Assessment-Guided Transcranial Magnetic Stimulation Maintenance Therapy for Prevention of Depression Relapse or Recurrence: Mental Health Diseases and Conditions – Depression
Insurance Daily News
2023 DEC 12 (NewsRx) -- By a
As a matter of record, on
Tracking Information
| Trial Identifier | NCT06145594 |
| First Submitted Date | |
| First Posted Date | |
| Results First Submitted Date | Not Provided |
| Results First Posted Date | Not Provided |
| Last Update Submitted Date | |
| Last Update Posted Date | |
| Primary Completion Date | |
| Actual Start Date | |
| Current Primary Outcome Measures | •Weeks in |
| Current Secondary Outcome Measures | Not Provided |
| Other Outcome Measures | Not Provided |
| Change History | Complete list of historical revisions of study NCT06145594 |
Descriptive Information
| Brief Title | EMA-Guided Maintenance TMS for Depression |
| Official Title | Ecological Momentary Assessment-Guided Transcranial Magnetic Stimulation Maintenance Therapy for Prevention of Depression Relapse or Recurrence |
| Brief Summary | The goal of this study is to evaluate the use of ecological-momentary-assessment (EMA) as a method for scheduling maintenance treatments for patients with Major Depressive Disorder (MDD) who responded to an initial acute course of Transcranial Magnetic Stimulation (TMS). To assess symptom re-emergence and severity over time, the Patient Health Questionnaire-9 item (PHQ-9) will be administered weekly via a prompt with a link send to a participants’ smartphones. Adaptive algorithm software will monitor each participant’s PHQ-9 scores over time and determine when a threshold increase in symptoms has occured and maintenance TMS sessions should be offered. Participants in this study will be randomized to either receive weekly EMA (monitoring only) or weekly EMA with maintenance TMS sessions (scheduled as indicated by the EMA algorithm). Participation for each subject will last for one year, with maintenance TMS offered as an adjunct to ongoing treatment as usual (TAU) for depression, i.e., ongoing pharmacotherapy, psychotherapy. |
| Detailed Description | Repetitive Transcranial Magnetic Stimulation (rTMS or simply ‘”TMS”) is a FDA approved non-invasive treatment modality for treatment-resistant MDD. While the current standard of care defines the treatment schedule for an acute course (i.e., 30 sessions delivered once daily over 6 weeks, followed by several weeks of sessions in a taper schedule), there is no current standard for scheduling maintenance TMS sessions to keep patients well after they have completed an initial course of TMS Therapy. Several prospective studies show that re-introduction of TMS is highly successful for rescuing patients who have MDD symptom relapse, but those trials used serial assessment of depressive symptoms at regular intervals over time and applied specific criteria for triggering the re-introduction of TMS treatments - a method which has not been translated to real-life clinical practice. Follow-up data show TMS responders are highly variable with regard to how long they will sustain their benefits after completing the course of TMS; some will sustain response/remission for years while others will relapse after weeks or months. One randomized prospective study that aimed to prevent depressive episode relapse with maintenance TMS showed that a fixed (once per month) treatment schedule was not better than “watchful waiting” with threshold symptom-triggered TMS sessions. It is clear that there is not a “once size fits all” treatment schedule that should be applied for TMS maintenance therapy. Considering the wide range in durability of effect, a personalized approach is needed for determining when TMS maintenance treatments should be given. This study evaluates a convenient method for monitoring symptoms over time and a customized approach to scheduling maintenance TMS sessions on an individual-patient basis, with the “trigger” for re-introduction of TMS treatments driven by patient-specific change in MDD symptoms. Ecological Momentary Assessment (EMA) involves measurement of symptoms in the real-life daily environment in which a patient lives, works, and functions, rather than in the research or clinic setting. One popular method for EMA involves using applications that are downloaded to a patient’ smartphone or cloud-based software platforms which can sed a text message prompt to the patient at pre-set times so the patient can report about their symptoms. This study will evaluate whether a method that uses EMA assessments (weekly PHQ-9 surveys) and adaptive algorithm software can be used to schedule maintenance TMS sessions for MDD patients who have responded to a standard acute course of TMS therapy. MDD patients who initially responded to a standard course of TMS at |
| Study Type | Interventional |
| Study Phase | Not Applicable |
| Study Design | Allocation: Randomized |
| Intervention Model: Parallel Assignment | |
| Primary Purpose: Prevention | |
| Masking: None (Open Label) | |
| Intervention Model Description: Randomized, 2 parallel groups (EMA or EMA+mTMS) with longitudinal follow-up (with EMA monitoring) over 1 year. open-label mTMS and other concurrent treatment as usual (TAU) for bother groups; Adjunct mTMS is offered if/when determined by software algorithm for EMA+mTMS group only. | |
| Condition | Major Depressive Disorder |
| Intervention | •Other: EMA Monitoring |
| Weekly prompts to participants’ smartphones for collection of PHQ-9 data | |
| •Other: Scheduling Maintenance TMS sessions | |
| When threshold score is reached, the participants is offered TMS maintenance treatments | |
| Study Arms | •Active Comparator: EMA only |
| Weekly EMA monitoring without sheduled maintenance TMS. Participants in this arm may get TMS retreatment according to current standard of care (i.e., through their insurance coverage). Partcipants continue other concurrent treat | |
| Interventions: | |
| ⚬Other: EMA Monitoring | |
| •Experimental: EMA+Maintenance TMS | |
| Weekly EMA monitoring and a cluster of 5 maintenance sessions scheduled if/when PHQ9 scores reach threshold, per algorithm. Participants contiue other concurrent treatment as usual (TAU) with medications, psychotherpy, etc per o | |
| Interventions: | |
| ⚬Other: EMA Monitoring | |
| ⚬Other: Scheduling Maintenance TMS sessions |
Recruitment Information
| Recruitment Status | Recruiting |
| Estimated Enrollment | 30 |
| Estimated Completion Date | |
| Primary Completion Date | |
| Eligibility | Inclusion Criteria: Patients with primary Major Depressive Disorder who responded (50% drop in score from pre-treatment baseline to final score on depression scale) to a standard acute course of TMS Therapy at |
| Sex/Gender | Sexes Eligible for Study: All |
| Ages | 18 years and older |
| No | |
| Contacts | Primary contact: |
| Backup contact: |
|
| Listed Location Countries | |
| Removed Location Countries |
Administrative Information
| NCT Number | NCT06145594 |
| Other Study ID Numbers | 1503374 |
| Has Data Monitoring Committee | Not Provided |
| Not Provided | |
| Plan to Share Data | No |
| Plan to Share Data (IPD) Description | Not Provided |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: |
| Information Provided By | |
| Verification Date |
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