RECRUITING

Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches

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Conditions

TBI (Traumatic Brain Injury)HeadacheDepressionrTMStranscranial magnetic stimulationtherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Combined Nonpharmacological Therapies for MTBI-Related Headaches

Quick Facts

Study Start:2022-01-01
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05176392

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Mild Traumatic Brain Injury (mTBI)
  2. 2. Chronic headaches \> 3 months after injury
  3. 3. Aged 18-65
  4. 4. No prior TMS treatment
  5. 5. Persistent Headaches with an intensity \> 30 / 100
  6. 6. No history of daily headache prior to mTBI
  1. 1. Pregnant
  2. 2. Pacemaker or any metal in body that would prevent MRI
  3. 3. History of dementia or major psychiatric disease, such as bipolar disorder or schizophrenia
  4. 4. Presence of any other chronic neuropathic pain states
  5. 5. History of seizure
  6. 6. Pending litigation
  7. 7. Can't understand English
  8. 8. History of chronic headache like migraine prior to mTBI
  9. 9. Evidence in chart of exacerbation of depressive/anxiety symptoms, active substance dependence, suicidal intent or attempt within previous month

Contacts and Locations

Study Contact

Caleb Lopez, BS
CONTACT
858-552-8585
caleb.lopez@va.gov

Principal Investigator

Albert Y Leung, MD
PRINCIPAL_INVESTIGATOR
San Diego Veterans Healthcare System

Study Locations (Sites)

VA San Diego Healthcare System
San Diego, California, 92161
United States

Collaborators and Investigators

Sponsor: Veterans Medical Research Foundation

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-01
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2022-01-01
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

  • rTMS
  • transcranial magnetic stimulation
  • therapy

Additional Relevant MeSH Terms

  • TBI (Traumatic Brain Injury)
  • Headache
  • Depression