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Transcranial Magnetic Stimulation

rTMS and Headache Management for mTBI-Related Headaches

N/A
Recruiting
Led By Albert Leung, MD
Research Sponsored by Veterans Medical Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No history of daily headache prior to mTBI
Persistent Headaches with an intensity > 30 / 100
Must not have
Can't understand English
History of seizure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit

Summary

This trial will study whether combining two different types of therapy can help manage headaches related to mild traumatic brain injury.

Who is the study for?
This trial is for adults aged 18-65 who have had a mild traumatic brain injury (mTBI) and suffer from persistent headaches that started after their injury. They must not have received TMS treatment before, and their headache intensity should be over 30 on a scale of 100. People with metal implants, seizure history, major psychiatric diseases, or chronic pain conditions other than mTBI-related headaches cannot participate.
What is being tested?
The study tests if active repetitive transcranial magnetic stimulation (rTMS), combined with telehealth therapy, can reduce headaches caused by mild traumatic brain injuries better than placebo treatments. Participants will either receive the real rTMS treatment along with headache management therapy or sham rTMS with basic headache education.
What are the potential side effects?
rTMS may cause discomfort at the site of application, lightheadedness, tingling sensations during the procedure, brief episodes of muscle twitching or spasms. Rarely it could induce seizures but is generally considered safe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I did not have daily headaches before my mild brain injury.
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I experience severe headaches rated over 30 on a scale of 100.
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I am between 18 and 65 years old.
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I have had chronic headaches for more than 3 months after an injury.
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I have never received TMS treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot understand English.
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I have had seizures in the past.
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I have long-term nerve pain conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Debilitating Headache Frequency
Debilitating Headache Interference
Intensity of Debilitating Headaches
+2 more
Secondary study objectives
Mental Depression
Headache Impact Test
Neurobehavioral Symptom Inventory
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Sham rTMS with telehealth headache management therapyExperimental Treatment2 Interventions
Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management
Group II: Active rTMS with telehealth headache education controlExperimental Treatment2 Interventions
Participants receive active rTMS treatment at the left dorsolateral prefrontal cortex and headache education
Group III: Active rTMS with telehealth headache management therapyActive Control2 Interventions
Participants receive both active rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management
Group IV: Sham rTMS with telehealth headache education controlPlacebo Group2 Interventions
Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and headache education
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active rTMS
2019
Completed Phase 2
~400
Sham rTMS
2008
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

Veterans Medical Research FoundationLead Sponsor
44 Previous Clinical Trials
4,766 Total Patients Enrolled
Albert Leung, MDPrincipal InvestigatorSan Diego Veterans Healthcare System
Albert Y Leung, MDPrincipal InvestigatorSan Diego Veterans Healthcare System
1 Previous Clinical Trials
29 Total Patients Enrolled

Media Library

Active rTMS (Transcranial Magnetic Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05176392 — N/A
Traumatic Brain Injury Research Study Groups: Active rTMS with telehealth headache education control, Active rTMS with telehealth headache management therapy, Sham rTMS with telehealth headache management therapy, Sham rTMS with telehealth headache education control
Traumatic Brain Injury Clinical Trial 2023: Active rTMS Highlights & Side Effects. Trial Name: NCT05176392 — N/A
Active rTMS (Transcranial Magnetic Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05176392 — N/A
~50 spots leftby Aug 2025
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