← Back to Search

Other

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 below

Select...

I am between 18 and 65 years old.

Select...

My psychiatric medication has been stable or I've been medication-free for 4 weeks.

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and before treatment, two weeks after treatment ends, and 3, 6, 9, and 12 months after treatment for reporting.

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 more

Awards & 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

~760

0 / 3Eligibility criteria met