Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches

Официальное название

Combined Nonpharmacological Therapies for MTBI-Related Headaches

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Active rTMS
  Active rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil.
• Поведенческое Headache Management Therapy
  Therapy will be provided on headache management.
• Устройство 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.
• Поведенческое Headache Education Control
  In the control, educational sessions on headaches will be provided.

Первичные конечные точки

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

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• VA San Diego Healthcare System — San Diego

Идентификаторы

NCT: NCT05176392 · CP200229 · W81XWH2110831 · H210076

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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