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Individualized TMS for Depression (AINT Trial)

Phase 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights

AINT Trial Summary

This trial tests the benefit of using brain imaging to find the best spot for a depression treatment. Participants won't know how the spot was found.

Who is the study for?
This trial is for adults with major depressive disorder who haven't responded well to other treatments. They must speak English, maintain their usual caffeine intake, not use tobacco on treatment days, and avoid alcohol before MRI and TMS sessions. Pregnant individuals or those trying to become pregnant cannot participate.Check my eligibility
What is being tested?
The study tests aiTBS (a type of brain stimulation) for depression treatment effectiveness. Participants will receive aiTBS without knowing if the targeted area was chosen using neuroimaging or standard head measurements.See study design
What are the potential side effects?
aiTBS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. Most side effects are mild and temporary but can vary between individuals.

AINT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Beck Anxiety Inventory (BAI)
Beck Depression Inventory (BDI)
Change in resting state functional connectivity in the depression network
+8 more

AINT Trial Design

2Treatment groups
Experimental Treatment
Group I: sham individualized resting state functional connectivity targetingExperimental Treatment1 Intervention
Participants in this group will receive aiTBS with neuronavigation to a treatment target identified with head measurements (i.e., Beam F3)
Group II: real individualized resting state functional connectivity targetingExperimental Treatment1 Intervention
Participants in this group will receive aiTBS with neuronavigation to a treatment target identified with individualized resting state functional connectivity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcranial magnetic stimulation
2013
Completed Phase 2
~710

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,616 Previous Clinical Trials
11,470,908 Total Patients Enrolled
Joseph J Taylor, MD, PhDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

aiTBS (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05680727 — Phase 2
Major Depressive Disorder Research Study Groups: real individualized resting state functional connectivity targeting, sham individualized resting state functional connectivity targeting
Major Depressive Disorder Clinical Trial 2023: aiTBS Highlights & Side Effects. Trial Name: NCT05680727 — Phase 2
aiTBS (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05680727 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research protocol include individuals of a younger age bracket?

"The inclusion requirement for this trial mandates that participants be between 22 and 80 years old."

Answered by AI

Could you explain the potential risk factors associated with transcranial magnetic stimulation?

"Transcranial magnetic stimulation has been evaluated and obtained a score of 2 for safety, indicating that while there is data corroborating its security, there are no reports on its efficacy at this time."

Answered by AI

What is the current enrollment quota for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical investigation is currently recruiting; it was initially posted on July 15th 2023 and updated most recently on August 8th of the same year. The trial requires 40 participants from a single study centre."

Answered by AI

Are there any available vacancies in this research protocol for participants?

"This healthcare trial, which was first publicised on July 15th 2023 and more recently updated on August 8th 2023 is still seeking enrollees. Clinicaltrials.gov confirms this information."

Answered by AI

Could I potentially be enrolled in this research experiment?

"This investigation seeks 40 individuals between 22 and 80 years old who suffer from clinical depression. Qualifying participants must be proficient in English, have a primary diagnosis of major depressive disorder as outlined by the DSM-V (assessed with MINI International Neuropsychiatric Interview), score higher than 20 on both BDI and MADRS scales, display moderate to severe treatment resistance according to the Maudsley Staging Method guidelines, remain stable on their antidepressant medication regimen or abstain for four weeks prior to treatment all throughout its duration (including follow-up assessments after 5 days). Furthermore, they need an ongoing clinician responsible for psychiatric care before/"

Answered by AI

Who else is applying?

What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I've tried other things that didn't work. I would like to try new treatments for depression.
PatientReceived no prior treatments
I’ve tried almost everything to help my depression and nothing helps me.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Individualized Functional Connectivity Targeting in aiTBS for Depression
Joseph J. Taylor, MD, PhD 2023. "Individualized Functional Connectivity Targeting in aiTBS for Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05680727.
All > Mdd > Transcranial Magnetic Stimulation
~27 spots leftby Jul 2026
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