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Behavioral Intervention

rTMS + ACT for Chronic Pain and Depression

N/A
Recruiting
Led By Matthew Herbert, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Average pain intensity and interference with enjoyment of life and/or general activity rated > 4/10 over the past week, as measured by the PEG
Meet clinical criteria for major depression via DSM5 criteria, as assessed by the Mini International Neuropsychiatric Interview (MINI)
Must not have
Contraindications to rTMS treatment as outlined by the Safety of TMS Consensus group, which includes implanted metallic objects above the neck, implanted electrical devices (pacemakers/spinal cord stimulators), and pregnancy
Serious or unstable medical illness (e.g., cardiovascular disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weekly during act intervention, 9 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will explore whether a novel approach that combines transcranial magnetic stimulation and acceptance and commitment therapy can help improve the quality of life for veterans with chronic pain and depression.

Who is the study for?
This trial is for veterans with chronic pain (pain most days for at least 6 months) and major depression. Participants must have a pain intensity >4/10, not be undergoing unstable medical treatments or substance abuse, and cannot have tried rTMS before or had no response to electroconvulsive therapy.
What is being tested?
The study tests combining repetitive Transcranial Magnetic Stimulation (rTMS) with Acceptance and Commitment Therapy to improve function in veterans suffering from chronic pain and depression. It's a preliminary step towards a larger efficacy trial.
What are the potential side effects?
Potential side effects of rTMS may include discomfort at the treatment site, headache, lightheadedness, seizures (rare), or hearing loss if ear protection isn't used during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pain has been over 4/10 and affects my life and activities.
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I have been diagnosed with major depression according to DSM5.
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I have been in pain most days for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have metal implants above the neck, electrical devices like pacemakers, or am not pregnant.
Select...
I do not have any serious or unstable illnesses like heart disease.
Select...
I have tried rTMS or did not respond to electroconvulsive therapy.
Select...
I have a significant neurological disorder or a history of seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weekly during act intervention, 9 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weekly during act intervention, 9 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PROMIS Pain Interference change
Secondary study objectives
PROMIS Pain Intensity change
Patient Health Questionnaire-9 (PHQ-9) change

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DLPFC-rTMS + ACTExperimental Treatment2 Interventions
Active DLPFC-rTMS with ACT treatment
Group II: Sham-rTMS + ACTActive Control1 Intervention
Sham delivered rTMS with ACT treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acceptance and Commitment Therapy
2010
Completed Phase 1
~1490
Repetitive Transcranial Magnetic Stimulation
2013
Completed Phase 3
~1170

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,645 Total Patients Enrolled
78 Trials studying Depression
19,954 Patients Enrolled for Depression
Matthew Herbert, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
1 Previous Clinical Trials
126 Total Patients Enrolled

Media Library

Acceptance and Commitment Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05427201 — N/A
Depression Research Study Groups: DLPFC-rTMS + ACT, Sham-rTMS + ACT
Depression Clinical Trial 2023: Acceptance and Commitment Therapy Highlights & Side Effects. Trial Name: NCT05427201 — N/A
Acceptance and Commitment Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05427201 — N/A
~3 spots leftby Mar 2025
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