Recruiting

TMS & Therapy

Sponsor:

Veterans Medical Research Foundation

Code:

NCT05176392

Conditions

TBI (Traumatic Brain Injury)

Headache

Depression

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Active rTMS

Headache Management Therapy

Sham rTMS

Headache Education Control

Study Details

Brief summary:

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.

Conditions

TBI (Traumatic Brain Injury)

Headache

Depression

Study ID

NCT05176392

Start date

Jan 1, 2022

Status verified date

Nov, 2024

Completion date

Aug 31, 2025

Anticipated

Primary completion date

Aug 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Mild Traumatic Brain Injury (mTBI)
2. Chronic headaches > 3 months after injury
3. Aged 18-65
4. No prior TMS treatment
5. Persistent Headaches with an intensity > 30 / 100
6. No history of daily headache prior to mTBI

Exclusion Criteria:

1. Pregnant
2. Pacemaker or any metal in body that would prevent MRI
3. History of dementia or major psychiatric disease, such as bipolar disorder or schizophrenia
4. Presence of any other chronic neuropathic pain states
5. History of seizure
6. Pending litigation
7. Can't understand English
8. History of chronic headache like migraine prior to mTBI
9. Evidence in chart of exacerbation of depressive/anxiety symptoms, active substance dependence, suicidal intent or attempt within previous month

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active rTMS with telehealth headache management therapy

Participants receive both active rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management

other: Active rTMS with telehealth headache education control

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

other: Sham rTMS with telehealth headache management therapy

Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management

sham comparator: Sham rTMS with telehealth headache education control

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

Interventions

Active rTMS

Active rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil.

Headache Management Therapy

Therapy will be provided on headache management.

Sham rTMS

Sham rTMS will be given at the left dorsolateral prefrontal cortex. All parameters of the treatment will appear identical to the active treatment, with only the rTMS coil used to administer the treatment flipped 180 degrees to prevent stimulation.

Headache Education Control

In the control, educational sessions on headaches will be provided.

Primary outcome measure

  • Intensity of Persistent Headaches [ Time Frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit ]
  • Intensity of Debilitating Headaches [ Time Frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit ]
  • Persistent Headache Frequency [ Time Frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit ]
  • Debilitating Headache Frequency [ Time Frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit ]
  • Debilitating Headache Interference [ Time Frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit ]

Central Contacts and Locations

Central contacts

Caleb Lopez, BS

858-552-8585caleb.lopez@va.gov

Locations

VA San Diego Healthcare System

Recruiting

San Diego, California, United States, 92161

Contacts

Caleb Lopez, BS

858-552-8585caleb.lopez@va.gov

More Information

Sponsor

Veterans Medical Research Foundation

Last update posted

Nov 21, 2024

Last verified

Nov, 2024

Keywords

  • rTMS
  • transcranial magnetic stimulation
  • therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Veterans Medical Research Foundation on 2024-11-21.