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TMS for Depression (T5 Trial)
Phase < 1
Recruiting
Led By Joseph J Taylor, MD, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-65
Stable psychiatric medication regimen, or remain medication free, for 4 weeks prior to treatment and to remain on this regimen throughout the study until the two-week post-treatment visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before treatment and two weeks after treatment
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to test a new brain stimulation treatment for people with depression and another psychiatric disorder. They want to see if the treatment is safe and if it can help improve symptoms of depression and other disorders
Who is the study for?
This trial is for adults aged 18-65 with depression and another psychiatric disorder like anxiety, OCD, or PTSD. Participants must speak English well enough for consent and treatment, have a stable medication regimen or be medication-free for four weeks prior to the study, and show moderate to severe treatment resistance.
What is being tested?
The trial tests accelerated intermittent theta burst stimulation using transcranial magnetic stimulation (TMS) on the posterior parietal cortex. It aims to assess safety, symptom improvement in depression and other disorders, as well as changes in brain function.
What are the potential side effects?
While not specified here, TMS side effects can include headache, scalp discomfort at the site of stimulation, tingling or spasms of facial muscles, lightheadedness. Serious side effects are rare but may include seizures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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My psychiatric medication has been stable or I've been medication-free for 4 weeks.
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I have been diagnosed with anxiety, panic disorder, or social anxiety.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before treatment, two weeks after treatment ends, and 3, 6, 9, and 12 months after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before treatment, two weeks after treatment ends, and 3, 6, 9, and 12 months after treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility as measured by number of the 50 treatments completed
Tolerability as measured by incidence of side effects on an accelerated TMS sensations and adverse events questionnaire
Secondary study objectives
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision, Level 1 Self-Rated Cross-Cutting Symptom Measure (DSM-5-XC)
Montgomery-Åsberg Depression Rating Scale (MADRS)
World Health Organization Disability Assessment Schedule II (WHODAS 2.0)
Other study objectives
Adult Attention Deficit/Hyperactivity Disorder Self-Report Scale (AARS)
Beck Anxiety Inventory (BAI)
Beck Depression Inventory (BDI)
+13 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open-label aiTBS to posterior parietal cortexExperimental Treatment1 Intervention
10 iTBS treatment sessions per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses total). In the unlikely event that a participant is late for an hourly treatment, then the treatment will be delayed accordingly. The minimum gap between treatments will be 25 minutes. Each iTBS treatment will consist of 60 cycles of 10 bursts of three pulses at 50 Hz delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. Stimulation will be delivered at 90% resting motor threshold (rMT), adjusted for depth of the identified functional connectivity target.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcranial magnetic stimulation
2013
Completed Phase 2
~820
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,669 Previous Clinical Trials
11,877,806 Total Patients Enrolled
1 Trials studying Generalized Anxiety Disorder
180 Patients Enrolled for Generalized Anxiety Disorder
Joseph J Taylor, MD, PhDPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
40 Total Patients Enrolled