Patient-oriented Randomized Pragmatic Feasibility Trial with RTMS in Depression and Anxiety
NCT ID: NCT05028738
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2021-10-11
2025-08-31
Brief Summary
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Detailed Description
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Aim 1. To evaluate the feasibility of a future definite adaptive pragmatic RCT comparing left vs right DLPFC repetitive transcranial magnetic stimulation (rTMS) in TRD.
Hypothesis 1a: Enrollment will be 70% of the planned target over the 1-year recruitment period.
Hypothesis 1b: Retention rate of randomized participants will be ≥70% at the end of the intervention in both groups.
Aim 2. To evaluate patients' preferences regarding information about treatment options when there is no response to allocated treatment.
Hypothesis 2: Patients will prefer to modify treatment when there is no response.
Aim 3. To assess the feasibility of digital phenotyping as an tool to investigate biomarkers in TRD.
Hypothesis 3a: Survey uptake and participation in the study regarding the use of digital phenotyping will be 80% of randomized participants. Hypothesis 3b: Of those survey responders, 75% will indicate they would consent to digital phenotyping in a future definite RCT.
Aim 4. To develop a Bayesian statistical model that continuously updates personalized treatment effect estimates as the trial progresses, and identify the circumstances under which use of the model in a full-scale trial could inform treatment choice as the trial progresses.
Hypothesis 4: The modeling results will identify at least one subgroup for whom early stopping of the definitive trial in that subgroup may be warranted.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intermittent Theta Burst Stimulation (iTBS)
iTBS to the L-DLPFC
Repetitive Transcranial Magnetic Stimulation
rTMS will employ the MagPro X100 stimulator equipped with the cool-B70 coil (MagVenture, Farum, Denmark). The dose will be a 120% resting motor threshold (rMT) in accordance to our latest trial using iTBS. Localization of the right and left DLPFC will follow the well-established Beam F3 procedure. Subjects will then undergo 30 sessions of rTMS, once daily on weekdays for 6 weeks. FDA-approved iTBS protocol will consist of bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz for 600 pulses total, 2 s on, 8 s off, for 3 min 9 sec, at 120% rMT. LFR will consist of 1 Hz stimulation consisting of a single train of 10min duration for 600 pulses total at 120% rMT.
Low Frequency Right (LFR)
1Hz stimulation to the R-DLPFC
Repetitive Transcranial Magnetic Stimulation
rTMS will employ the MagPro X100 stimulator equipped with the cool-B70 coil (MagVenture, Farum, Denmark). The dose will be a 120% resting motor threshold (rMT) in accordance to our latest trial using iTBS. Localization of the right and left DLPFC will follow the well-established Beam F3 procedure. Subjects will then undergo 30 sessions of rTMS, once daily on weekdays for 6 weeks. FDA-approved iTBS protocol will consist of bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz for 600 pulses total, 2 s on, 8 s off, for 3 min 9 sec, at 120% rMT. LFR will consist of 1 Hz stimulation consisting of a single train of 10min duration for 600 pulses total at 120% rMT.
Interventions
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Repetitive Transcranial Magnetic Stimulation
rTMS will employ the MagPro X100 stimulator equipped with the cool-B70 coil (MagVenture, Farum, Denmark). The dose will be a 120% resting motor threshold (rMT) in accordance to our latest trial using iTBS. Localization of the right and left DLPFC will follow the well-established Beam F3 procedure. Subjects will then undergo 30 sessions of rTMS, once daily on weekdays for 6 weeks. FDA-approved iTBS protocol will consist of bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz for 600 pulses total, 2 s on, 8 s off, for 3 min 9 sec, at 120% rMT. LFR will consist of 1 Hz stimulation consisting of a single train of 10min duration for 600 pulses total at 120% rMT.
Eligibility Criteria
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Inclusion Criteria
2. are voluntary and competent to consent to treatment;
3. are ≥ 18 years;
4. have a score ≥ 26 on the IDS-30-SR;
5. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
6. able to adhere to the treatment schedule;
7. pass the TMS adult safety screening (TASS) questionnaire
Exclusion Criteria
2. are pregnant;
3. have a lifetime diagnosis of schizophrenia, bipolar disorder type I, schizophreniform, schizoaffective disorder or presence of psychotic symptoms within last 3 months;
4. have a concomitant major unstable medical illness;
5. have any significant form of dementia or any history of epilepsy;
6. have any intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
7. If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study;
8. If they are taking psychotropic medication, be on a stable dose for 4 weeks before starting treatment, and no initiation of new regular psychotropic medication;
9. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
10. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
18 Years
ALL
No
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA
Principal Investigator
Principal Investigators
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Fidel Vila-Rodriguez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Non-Invasive Neurostimulation Therapies (NINET) Laboratory, UBC Department of Psychiatry
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Afifa Humaira, B.Sc.
Role: primary
Fidel Vila-Rodriguez, M.D., Ph.D.
Role: backup
Other Identifiers
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H17-00161
Identifier Type: -
Identifier Source: org_study_id