Brain Stimulation for Concussion

NCT05889117 | Active Not Recruiting FDA Device

• 1 other identifier: 23-110
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test a new type of magnetic brain stimulation in patients with persistent post-concussive symptoms. Participants will undergo detailed MRI scans before and after 30 treatment sessions (of 3-10 minutes each). The main questions the study aims to answer are:

• Will this new type of treatment result in fewer symptoms and better daily functioning?
• What are the effects of this treatment on brain functioning?

Conditions

Transcranial Magnetic Stimulation; Magnetic Resonance Imaging; Neuropsychological Tests; Traumatic Brain Injury; Post-Concussion Syndrome

Keywords

Transcranial Magnetic Stimulation; Magnetic Resonance Imaging; Neuropsychological Tests; Traumatic Brain Injury; Post-Concussion Syndrome; TMS; Theta-burst; Diffusion magnetic resonance spectroscopy

Outcome Measures

Primary Outcomes (2)

• Post-concussive symptoms

  Rivermead post concussion symptoms questionnaire (16 items, rated 0-4, higher number indicating more symptoms, max score of 64; decrease of the score means improvement of symptoms)

  Post-treatment (after completion of all sessions, at ~4 weeks), and at 3 months after start of the study for the individual participant. Data will be reported at the conclusion of the study for all participants.

• Neurometabolite diffusion related to neuronal function and inflammation

  As measured with diffusion MRS (diffusion of neurometabolites computed as the apparent diffusion coefficient (ADC)).

  Post-treatment for the individual participant (~4 weeks). Data will be reported at the conclusion of the study for all participants.

Secondary Outcomes (3)

• Cognitive functioning

  Post-treatment for the individual participant (~4 weeks). Data will be reported at the conclusion of the study for all participants.

• Functional outcome

  At 3 months after start of the study for the individual participant. Data will be reported at the conclusion of the study for all participants.

• Brain network functioning

  Post-treatment for the individual participant (~ 4 weeks). Data will be reported at the conclusion of the study for all participants.

Study Arms (1)

Waitlist-control-treatment-group

EXPERIMENTAL

After a 2-week control waitlist period, patient receive 30 treatments.

Device: Intermittent theta-burst treatment (iTBS) using MagPro Transcranial Magnetic Stimulator (manufacturer: Magventure)

Interventions

Intermittent theta-burst treatment (iTBS) using MagPro Transcranial Magnetic Stimulator (manufacturer: Magventure) DEVICE

3-10 minute sessions of brain stimulation applied to the left dorsolateral prefrontal cortex, up to 10 sessions a day, 30 sessions in total, planned within 2 weeks.

Also known as: transcranial magnetic stimulation (TMS)

Waitlist-control-treatment-group

Eligibility Criteria

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

You may qualify if:

• mTBI as defined by an altered mental status at time of injury, and LOC of max 30 min, GCS 13-15 (after 30 min), and PTA max 24 hrs.
• Persistent post-traumatic symptoms in chronic phase (\>3 months post-injury).

You may not qualify if:

• History of developmental, neurological (e.g., epilepsy) or serious mental health disorders (e.g., schizophrenia, bipolar disorder) prior to TBI onset.
• History of a previous substance use disorder except for alcohol, or a currently active substance use disorder (within last 6 months.)
• Contraindications for MRI (e.g., any implanted ferromagnetic materials, claustrophobia, pregnancy) or iTBS (e.g., history of seizures).

Sponsors & Collaborators

• The Mind Research Network: lead
• University of New Mexico: collaborator

Study Sites (1)

The Mind Research Network

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Post-Concussion Syndrome

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Harm J van der Horn, MD PhD

  Mind Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group waitlist-control

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: June 5, 2023
• Study Start: October 30, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)