Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches

Official title

Combined Nonpharmacological Therapies for MTBI-Related Headaches

Overview

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.

Detailed description

This study will be enrolling a total of 240 veterans or active military over a 4 year period at the VA San Diego Healthcare System (VASDHS). Participants will be randomized into one of four groups:

Group A: active rTMS with telehealth headache management therapy Group B: active rTMS with telehealth headache education control Group C: sham rTMS with telehealth headache management therapy Group D: sham rTMS with telehealth headache education control

Individual participation will consist of 19 visits to the VASDHS and 11 telehealth sessions over the course of 6-7 months. The in person visits will be divided into the following phases:

1. PRE-TREATMENT ASSESSMENTS PHASE (weeks 1-2) which consists of Visit 1 (Screening Visit) and Visit 2 (Baseline Assessments with MRI scan); 2. INDUCTION TREATMENT PHASE (weeks 3-4) consists of Visits 3-12 (10 weekday neuronavigation guided rTMS sessions at \>24 and \<72 hours apart); and 3. POST-TREATMENT ASSESSMENTS AND MAINTENANCE TREATMENT PHASE (weeks 5-24) consists of 4 initial biweekly post-induction treatment assessments and maintenance treatments (Visits 13-16)) and two additional monthly post-induction assessments and maintenance treatments (Visits 17-18) and one final study visit (Visit 19).

Eight weekly telehealth therapy/education sessions will be conducted from week 3 to 10 with additional three bolster sessions at 4 weeks apart. During the baseline and follow up visits, assessments will be conducted to evaluate headaches, neurobehavioral symptoms, depressive symptoms, post-concussion symptoms, and quality of life.

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.

Primary outcome measures

• 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]

Secondary outcome measures (6)

• Headache Impact Test [Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit]
• Neurobehavioral Symptom Inventory [Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit]
• Hamilton Rating Scale for Depression [Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit]
• Rivermead Post-Concussion Symptoms Questionnaire [Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit]
• Short Form Health Survey-36 [Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit]
• Short-Form NEURO-QoL [Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• VA San Diego Healthcare System — San Diego

Identifiers

NCT: NCT05176392 · CP200229 · W81XWH2110831 · H210076

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗