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Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches

NCT05176392 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-11-21

No results posted yet for this study

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

Interventions

DEVICE

Active rTMS

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

BEHAVIORAL

Headache Management Therapy

Therapy will be provided on headache management.

DEVICE

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.

BEHAVIORAL

Headache Education Control

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

Sponsors & Collaborators

  • Veterans Medical Research Foundation

    lead OTHER

Principal Investigators

  • Albert Y Leung, MD · San Diego Veterans Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2025-08-31
Completion
2025-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05176392 on ClinicalTrials.gov