Status:
NOT_YET_RECRUITING
Personalized Brain Stimulation to Treat Chronic Concussive Symptoms
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
United States Department of Defense
Conditions:
Post-Concussion Syndrome
Concussion, Brain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The goal of this study is to investigate a new treatment for chronic symptoms after concussion or mild traumatic brain injury in people aged 18-65 years old. Chronic symptoms could include dizziness, ...
Detailed Description
The overall objective of the proposed project is to apply a well-studied and safe form of brain modulation to patients with chronic symptoms after concussion. These patients represent a vulnerable pop...
Eligibility Criteria
Inclusion
- Mild traumatic brain injury (mTBI) defined in accord with the World Health Organization criteria in the last 12 months
- age 18-65 at the time of the mTBI
- high burden of post-concussive symptoms defined as a score \>=20 on the Rivermead Post-Concussion Symptoms Questionnaire
Exclusion
- objective neurologic deficits
- ongoing or prolonged (\>3 months) post-concussive symptoms from a prior mTBI within 2 years of the index injury
- history of transcranial magnetic stimulation (TMS) therapy
- contraindications for TMS or magnetic resonance imaging (MRI) (e.g., metallic implant other than dental, pacemaker)
- severe mental, physical, or medical problems that would impede participation or pose a risk for the planned intervention (e.g., liver, kidney, or heart disease, uncontrolled diabetes or hypertension, malignancy, psychosis, previous seizure, pregnancy)
- active alcohol or illicit drug abuse
- inability to speak and read English
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06073886
Start Date
January 1 2024
End Date
January 1 2026
Last Update
October 10 2023
Active Locations (1)
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1
UCLA
Westwood, Los Angeles, California, United States, 90095