Active rTMS with telehealth headache management therapy for Traumatic Brain Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
VA San Diego Healthcare System, San Diego, CATraumatic Brain Injury+2 MoreActive rTMS - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Traumatic Brain Injury
  • Headache
  • Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 6 Secondary · Reporting Duration: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit

Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Debilitating Headache Frequency
Debilitating Headache Interference
Mental Depression
Headache Impact Test
Intensity of Debilitating Headaches
Intensity of Persistent Headaches
Neurobehavioral Symptom Inventory
Persistent Headache Frequency
Rivermead Post-Concussion Symptoms Questionnaire
Short Form Health Survey-36
Short-Form NEURO-QoL

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Active rTMS with telehealth headache management therapy
1 of 2
Sham rTMS with telehealth headache education control
1 of 2

Active Control

Non-Treatment Group

240 Total Participants · 2 Treatment Groups

Primary Treatment: Active rTMS with telehealth headache management therapy · Has Placebo Group · N/A

Active rTMS with telehealth headache management therapyActiveComparator Group · 2 Interventions: Active rTMS, Headache Management Therapy · Intervention Types: Device, Behavioral
Sham rTMS with telehealth headache education controlShamComparator Group · 2 Interventions: Sham rTMS, Headache Education Control · Intervention Types: Device, Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit

Who is running the clinical trial?

Veterans Medical Research FoundationLead Sponsor
40 Previous Clinical Trials
4,337 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

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a minor injury to your head.
You have been experiencing long-term headaches for more than 3 months after an injury.
You have never received TMS treatment before.
You have ongoing headaches that are very strong, with a pain level above 30 out of 100.
You did not have daily headaches before the mild traumatic brain injury (mTBI).

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.