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

NCT ID: NCT06398665

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-29
• Study Completion Date: 2026-03-31

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.

Detailed Description

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). PCS is characterized by symptoms like cognitive impairment, mood dysregulation, fatigue, and headaches, with limited treatment options. Previous research has indicated brain network dysfunction in mTBI patients and suggested the potential of conventional once daily high frequency rTMS for treating PCS symptoms. Our proposal builds on these findings by utilizing the expertise and resources of Sunnybrook's Harquail Centre for Neuromodulation, which has extensive experience in delivering rTMS and theta-burst stimulation for treatment-resistant depression. This pilot study will implement an accelerated iTBS rTMS protocol, offering shorter treatment duration, as well as MRI-guided stimulation for precise targeting. The investigators will also explore changes in brain function following rTMS using a technique called functional magnetic resonance imaging. The investigators ultimately aim to understand how iTBS may alter the post-concussive brain and the extent to which these changes may improve PCS.

Conditions

Post-Concussion Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Accelerated Intermittent Theta-Burst Stimulation

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

Group Type: EXPERIMENTAL

Intermittent Theta-Burst Stimulation

Intervention Type: 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)

Interventions

Intermittent Theta-Burst Stimulation

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)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sean Michael Nestor

clinician-investigator and interventional psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Sean M Nestor, MD

Role: CONTACT

sean.nestor@sunnybrook.ca

416-480-4085

Erica S Reyvas, BA

Role: CONTACT

erica.reyvas@sri.utoronto.ca

416-480-4053

Facility Contacts

Sean M Nestor, MD

Role: primary

sean.nestor@sunnybrook.ca

416-480-4085

Other Identifiers

6160

Identifier Type: -

Identifier Source: org_study_id