Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome - Open-label Pilot Study

NCT06398665 | Recruiting

• 1 other identifier: 6160
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The current study aims to better understand the efficacy of intermittent theta-burst stimulation (iTBS) treatment in patients diagnosed with post-concussion syndrome (PCS) and to explore changes in brain networks after undergoing iTBS to assess its safety and feasibility in treating PCS.

Conditions

Post-Concussion Syndrome

Outcome Measures

Primary Outcomes (3)

• Rivermead Post-Concussion Symptoms Questionnaire

  A validated measure of subjective global PCS symptoms

  Baseline, immediately before the first iTBS treatment

• Rivermead Post-Concussion Symptoms Questionnaire

  A validated measure of subjective global PCS symptoms

  5 days

• Rivermead Post-Concussion Symptoms Questionnaire

  A validated measure of subjective global PCS symptoms

  1 month post-treatment

Secondary Outcomes (4)

• Montgomery-Asberg Depression Rating Scale

  Baseline, post treatment day 5, and Study endpoint

• Repeatable Battery for the Assessment of Neuropsychological Status

  Baseline and post treatment 1 month

• The Behavior Rating Inventory of Executive Function

  Baseline, post treatment day 5, and post treatment 1 month

• Headache Impact Test

  Baseline and post treatment 1 month

Study Arms (1)

Accelerated Intermittent Theta-Burst Stimulation

EXPERIMENTAL

Non-invasive brain stimulation technique, accelerated intermittent theta-burst stimulation (iTBS) repetitive transcranial magnetic stimulation (rTMS), for treating post- concussive syndrome (PCS) in persons with mild traumatic brain injury

Device: Intermittent Theta-Burst Stimulation

Interventions

Intermittent Theta-Burst Stimulation DEVICE

Accelerated course of left dlPFC iTBS, consisting of 600 pulses/session, 50 minutes intersession interval, 8 session/day for 5 days) at 90% resting motor threshold (MT)

Accelerated Intermittent Theta-Burst Stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Documented evidence of head trauma sufficiently severe to result in loss of consciousness, post-traumatic amnesia and/or acute altered mental status.
• At least three symptoms including headache, dizziness, fatigue, irritability, insomnia, memory difficulties, concentration difficulties, mood dysregulation.
• Onset of symptoms within 4 weeks following the head trauma.
• Age 18-60, inclusive.
• Persistence of PCS symptoms for at least 3 months but less than 24 months
• Able to provide informed consent and comply with the study protocol

You may not qualify if:

• Evidence of major structural neuroimaging abnormalities (e.g., intracranial hemorrhage, skull fracture or a large intracranial lesion)
• History of prior rTMS therapy,
• Contraindications to MRI (e.g., pacemaker, metallic implants etc.).
• Ferromagnetic, non-removable metallic implants from above the clavicle with the exception of dental work.
• Active personal injury litigation
• History of seizure disorder, not including febrile seizures in childhood
• Substance dependence within the last 6 months
• Pregnant
• Currently taking more than lorazepam 2 mg daily (or benzodiazepine equivalent) or any dose of an anticonvulsant (due to the potential to reduce rTMS efficacy)
• Currently taking an antiepileptic medication
• Mild and major comorbid medical conditions (as determined by investigators - e.g., neurological diseases, uncontrolled hypertension or diabetes, malignancy)
• A major comorbid psychiatric disorder (as determined by investigators - e.g., schizophrenia or bipolar disorder) and/or psychosis at the time of study enrollment.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

MeSH Terms

Conditions

Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Central Study Contacts

Sean M Nestor, MD

CONTACT

416-480-4085; sean.nestor@sunnybrook.ca

Erica S Reyvas, BA

CONTACT

416-480-4053; erica.reyvas@sri.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinician-investigator and interventional psychiatrist

Model Details: This open-label pilot study aims to investigate the potential of a non-invasive brain stimulation technique, accelerated intermittent theta-burst stimulation (iTBS) repetitive transcranial magnetic stimulation (rTMS), for treating post- concussive syndrome (PCS) in persons with mild traumatic brain injury (mTBI).

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 3, 2024
• Study Start: April 29, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

CA (1)