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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Debilitating Headache Frequency

Debilitating Headache Interference

Intensity of Debilitating Headaches

+2 more

Secondary outcome measures

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

~350

Sham rTMS

2008

Completed Phase 3

~1020

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Veterans Medical Research FoundationLead Sponsor

43 Previous Clinical Trials

4,694 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

Frequently Asked Questions

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

Is there an upper age limit for enrolment in this trial?

"According to the eligibility requirements, those wishing to partake in this trial must be between 18 and 65 years old. Additionally, there are 252 studies available for minors and 1149 studies designed for seniors."

Answered by AI

Who are the ideal participants for this clinical exploration?

"To be eligible for participation in this clinical trial, potential participants must experience headache symptoms and are required to fall within the 18-65 age range. In total, 240 people will take part of this research program."

Answered by AI

Is there any opportunity for participants to join this clinical experiment?

"According to information on clinicaltrials.gov, this study is currently enlisting participants. The trial was originally posted on January 1st 2022 and the details were last altered on September 23rd 2022."

Answered by AI

What is the current enrollment capacity for this medical study?

"Yes, the information available on clinicaltrials.gov confirms that this medical study is actively recruiting participants. The trial was first posted on January 1st 2022 and has been updated as of September 23rd 2022. This research requires 240 patients to be recruited from a single site."

Answered by AI

What objectives are researchers hoping to attain with this trial?

"This study is designed to measure the improvement of Debilitating Headache Frequency from baseline over a period of 20 weeks. Secondary objectives include assessing patients' quality of life with the Headache Impact Test, Hamilton Rating Scale for Depression, and Short Form Health Survey-36. Each objective uses an individual scoring rubric that ranges from 0 to 100 or 6 to 13 depending on the metric. Higher scores indicate a larger degree of negative impact in regards to quality of life variables."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combined Transcranial Magnetic Stimulation and Therapy for mTBI Related Headaches

2022. "Combined Transcranial Magnetic Stimulation and Therapy for mTBI Related Headaches". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05176392.

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