Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches

NCT05176392 | Recruiting FDA Device

• 3 other identifiers: CP200229W81XWH2110831H210076
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Keywords

rTMS; transcranial magnetic stimulation; therapy

Outcome Measures

Primary Outcomes (5)

• Intensity of Persistent Headaches

  Assesses the intensity of persistent headaches, from a scale of 0, being no pain, to 10, being worst possible pain.

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

• Intensity of Debilitating Headaches

  Assesses the intensity of debilitating headaches, from a scale of 0, being no pain, to 10, being worst possible pain.

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

• Persistent Headache Frequency

  Assesses the frequency per week of persistent headaches

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

• Debilitating Headache Frequency

  Assesses the frequency per week of debilitating headaches

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

• Debilitating Headache Interference

  Assesses the interference of debilitating headaches for activities of daily living, from 0, being no interference, to 10, being worst possible interference.

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

Secondary Outcomes (6)

• Headache Impact Test

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

• Neurobehavioral Symptom Inventory

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

• Hamilton Rating Scale for Depression

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

• Rivermead Post-Concussion Symptoms Questionnaire

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

• Short Form Health Survey-36

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

Study Arms (4)

Active rTMS with telehealth headache management therapy

ACTIVE COMPARATOR

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

Device: Active rTMS; Behavioral: Headache Management Therapy

Active rTMS with telehealth headache education control

OTHER

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

Device: Active rTMS; Behavioral: Headache Education Control

Sham rTMS with telehealth headache management therapy

OTHER

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

Behavioral: Headache Management Therapy; Device: Sham rTMS

Sham rTMS with telehealth headache education control

SHAM COMPARATOR

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

Device: Sham rTMS; Behavioral: Headache Education Control

Interventions

Active rTMS DEVICE

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

Active rTMS with telehealth headache education control; Active rTMS with telehealth headache management therapy

Headache Management Therapy BEHAVIORAL

Therapy will be provided on headache management.

Active rTMS with telehealth headache management therapy; Sham rTMS with telehealth headache management therapy

Sham rTMS DEVICE

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.

Sham rTMS with telehealth headache education control; Sham rTMS with telehealth headache management therapy

Headache Education Control BEHAVIORAL

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

Active rTMS with telehealth headache education control; Sham rTMS with telehealth headache education control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Veterans Medical Research Foundation: lead

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Headache; Depression

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Albert Y Leung, MD

  San Diego Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caleb Lopez, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The participant, study coordinators and the investigators will be blinded to the rTMS treatment. The participant will be blinded to the therapy group (headache management or headache education).
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will be randomized into one of 4 groups. Blocked randomization will be used with random block size of 4 or 8. Participants will be randomized to study groups in a 1:1:1:1 ratio.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: January 4, 2022
• Study Start: January 1, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

US (1)