Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches

Conditions

• Depression
• Headache
• TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jan 1, 2022

Status verified

Nov 2024

Primary completion

Aug 31, 2025

Completion

Aug 31, 2025

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Active rTMS with telehealth headache management therapy
  Participants receive both active rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management
• Other: Active rTMS with telehealth headache education control
  Participants receive active rTMS treatment at the left dorsolateral prefrontal cortex and headache education
• Other: Sham rTMS with telehealth headache management therapy
  Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management
• Sham Comparator: Sham rTMS with telehealth headache education control
  Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and headache education

Primary Outcome Measure

Intensity of Persistent Headaches [ Time Frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit ]

Central Contacts

• Caleb Lopez, BS
  858-552-8585
  [email protected]

Locations (1)

Find similar trials in San Diego, CA

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