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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 belowSelect...
I did not have daily headaches before my mild brain injury.
Select...
I experience severe headaches rated over 30 on a scale of 100.
Select...
I am between 18 and 65 years old.
Select...
I have had chronic headaches for more than 3 months after an injury.
Select...
I have never received TMS treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot understand English.
Select...
I have had seizures in the past.
Select...
I have long-term nerve pain conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
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 moreSecondary study objectives
Mental Depression
Headache Impact Test
Neurobehavioral Symptom Inventory
+3 moreTrial 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
4,777 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot understand English.I did not have daily headaches before my mild brain injury.I experience severe headaches rated over 30 on a scale of 100.I have had a mild traumatic brain injury.I am between 18 and 65 years old.I have had seizures in the past.I had chronic headaches or migraines before my brain injury.I have long-term nerve pain conditions.I have had chronic headaches for more than 3 months after an injury.I have never received TMS treatment.There is proof in your medical records of recent worsening of depression or anxiety, active addiction, or recent suicidal thoughts or actions.You have a history of severe memory loss or serious mental illness, like bipolar disorder or schizophrenia.
Research Study Groups:
This trial has the following groups:- Group 1: Active rTMS with telehealth headache education control
- Group 2: Active rTMS with telehealth headache management therapy
- Group 3: Sham rTMS with telehealth headache management therapy
- Group 4: Sham rTMS with telehealth headache education control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.