rTMS and Headache Management for mTBI-Related Headaches

Recruiting in Palo Alto (17 mi)

Overseen by Albert Y Leung, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Veterans Medical Research Foundation

Disqualifiers: Pregnant, Pacemaker, Dementia, Seizure, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will assess the combined effectiveness of repetitive transcranial magnetic stimulation (rTMS) and telehealth based therapy in helping manage mild traumatic brain injury (mTBI) related headaches. The investigators hypothesize that active rTMS combined with telehealth therapy will provide marked reduction in mTBI related headaches and symptoms in comparison to their placebo counterparts.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What data supports the effectiveness of the treatment rTMS for managing mTBI-related headaches?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can help reduce headaches related to mild traumatic brain injury (mTBI). Studies have found that rTMS, especially when applied to the left prefrontal cortex, can alleviate headaches and improve related symptoms, such as depression and cognitive issues, in people with mTBI. ^{1 2 3 4 5}

Is rTMS safe for humans?

Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe for humans, with common side effects like headache and discomfort usually improving over time. The most serious risk is seizures, but this is very rare, occurring in less than 0.1% of cases. ^{1 2 3 6 7}

How is the treatment for mTBI-related headaches using rTMS different from other treatments?

This treatment uses repetitive transcranial magnetic stimulation (rTMS), a non-invasive method that applies magnetic fields to stimulate nerve cells in the brain, which is different from conventional drug treatments that have not been effective for mTBI-related headaches. rTMS is unique because it targets the left dorsolateral prefrontal cortex to improve brain function and reduce headaches, and it is already approved for treating depression. ^{1 2 3 4 8}

Research Team

Albert Y Leung, MD

Principal Investigator

San Diego Veterans Healthcare System

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

I cannot understand English.

I have had seizures in the past.

I had chronic headaches or migraines before my brain injury.

Trial Timeline

Pre-Treatment Assessments

Participants are screened for eligibility to participate in the trial and undergo baseline assessments with MRI scan

2 weeks

2 visits (in-person)

Induction Treatment

Participants receive 10 weekday neuronavigation guided rTMS sessions

2 weeks

10 visits (in-person)

Post-Treatment Assessments and Maintenance Treatment

Participants undergo post-induction treatment assessments and maintenance treatments

20 weeks

7 visits (in-person)

Telehealth Therapy/Education

Participants receive telehealth therapy or education sessions

8 weeks

11 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Active rTMS (Transcranial Magnetic Stimulation)
• Headache Education Control (Behavioural Intervention)
• Headache Management Therapy (Behavioural Intervention)
• Sham rTMS (Transcranial Magnetic Stimulation)

Trial Overview 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.

Participant Groups

Group I: Sham rTMS with telehealth headache management therapy Experimental Treatment 2 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 control Experimental Treatment 2 Interventions

Participants receive active rTMS treatment at the left dorsolateral prefrontal cortex and headache education

Group III: Active rTMS with telehealth headache management therapy Active Control 2 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 control Placebo Group 2 Interventions

Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and headache education

Active rTMS is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as rTMS for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Smoking Cessation
• Chronic Pain Syndrome

🇪🇺 Approved in European Union as rTMS for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Chronic Pain Syndrome
• Generalized Anxiety Disorder (GAD)
• Bipolar Disorder

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

VA San Diego Healthcare System San Diego, CA

Who Is Running the Clinical Trial?

Veterans Medical Research Foundation

Lead Sponsor

Trials

46

Patients Recruited

5,100+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation in Managing Mild Traumatic Brain Injury-Related Headaches. Leung, A., Shukla, S., Fallah, A., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Dorsolateral Prefrontal Cortex rTMS in Alleviating MTBI Related Headaches and Depressive Symptoms. Leung, A., Metzger-Smith, V., He, Y., et al.[2022]

In a small study of 6 men with mild traumatic brain injury-related headaches (MTBI-HA), repetitive transcranial magnetic stimulation (rTMS) significantly reduced average headache intensity by 53% and the frequency of severe headache episodes by nearly 79%.

The rTMS treatment was well tolerated, suggesting it could be a promising non-invasive therapy for managing chronic pain from MTBI-HA, warranting further investigation in larger randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

rTMS in Alleviating Mild TBI Related Headaches--A Case Series. Leung, A., Fallah, A., Shukla, S., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

fMRI findings in MTBI patients with headaches following rTMS. Vaninetti, M., Lim, M., Khalaf, A., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive brain stimulation for persistent postconcussion symptoms in mild traumatic brain injury. Koski, L., Kolivakis, T., Yu, C., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation for migraine: a safety review. Dodick, DW., Schembri, CT., Helmuth, M., et al.[2010]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical Application and Safety of rTMS in Japan and Overseas]. Kito, S.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation in chronic tension-type headache: A pilot study. Mattoo, B., Tanwar, S., Bhatia, R., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation in Managing Mild Traumatic Brain Injury-Related Headaches. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Left Dorsolateral Prefrontal Cortex rTMS in Alleviating MTBI Related Headaches and Depressive Symptoms. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

rTMS in Alleviating Mild TBI Related Headaches--A Case Series. [2018]

4. England pubmed.ncbi.nlm.nih.gov

fMRI findings in MTBI patients with headaches following rTMS. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Noninvasive brain stimulation for persistent postconcussion symptoms in mild traumatic brain injury. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation for migraine: a safety review. [2010]

7. Japan pubmed.ncbi.nlm.nih.gov

[Clinical Application and Safety of rTMS in Japan and Overseas]. [2015]

8. India pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation in chronic tension-type headache: A pilot study. [2020]