Transcranial Magnetic StimulationNCT05889117
Brain Stimulation for Concussion
A study testing Intermittent theta-burst treatment (iTBS) using MagPro Transcranial Magnetic Stimulator (manufacturer: Magventure) in people with Transcranial Magnetic Stimulation and Magnetic Resonance Imaging, run by The Mind Research Network at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Transcranial Magnetic Stimulation, Magnetic Resonance Imaging, Neuropsychological Tests
- What is being tested?
- Intermittent theta-burst treatment (iTBS) using MagPro Transcranial Magnetic Stimulator (manufacturer: Magventure)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2023to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult age at inclusion 18-64 years.
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
The Mind Research Network
Albuquerque, New Mexico, 87106
About this study
Official title: Neurometabolic Effects of Theta-burst Treatment in Mild Traumatic Brain Injury
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?
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) seems a promising treatment option for patients with persistent post-concussive symptoms (PPCS). Traditional rTMS sessions are relatively long in duration and can be exhaustive for patients with PPCS. Intermittent theta-burst stimulation (iTBS) is a newer and more rapid form of rTMS, which only takes up to 10 minutes per session. However, little is known about the effects of iTBS in patients with PPCS. Furthermore, there is a pressing need for methods that reliably measure the effects of TMS treatments in-vivo. Using diffusion magnetic resonance spectroscopy (dMRS) changes in neural and glial cell morphology can be quantified, which makes it possible to disentangle neurometabolic changes related to neural injury and neuroinflammation, two key elements in the pathophysiology of mTBI.
In the current study, 15 patients with chronic (>3 months after mTBI) PPCS will undergo a total of 30 iTBS sessions. After a baseline scan, patients will enter a 2-week control waitlist period. Following the waitlist control, a pre-treatment scan is acquired, followed by the stimulation sessions, and final post-treatment scan. The scanning protocol includes T1 and T2 imaging, dMRS, multi-shell diffusion MRI (dMRI), as well as a demanding executive function fMRI task, and resting-state fMRI (rs-fMRI). A comprehensive battery of clinical tests will be administered at all time points, which includes cognitive testing, self-report of symptoms and emotional distress. Long-term outcome is determined three months after start of the study.
Specific study aims are:
Aim 1: To determine the effects of a precision-medicine iTBS guided approach applied to the left dorsolateral prefrontal cortex (DLPFC) on clinical recovery in patients with PPCS relative to waitlist control.
Aim 2: To determine the neurometabolic effects of iTBS in both the left and right DLPFC as measured with dMRS in patients with PPS, and to untangle differential effects on pathophysiological processes (e.g., neural plasticity vs. anti-inflammatory effects).
Aim 3: To determine the relationship of these neurometabolic effects and the integrity of major frontoparietal white matter tracts (as measured with dMRI), as well as activation and functional connectivity of key large-scale cognitive and emotional networks (i.e., executive, default mode, and salience network), measured using task-based and resting-state fMRI.
- Conditions
- Transcranial Magnetic Stimulation, Magnetic Resonance Imaging, Neuropsychological Tests, Traumatic Brain Injury, Post-Concussion Syndrome
- Being tested
- Intermittent theta-burst treatment (iTBS) using MagPro Transcranial Magnetic Stimulator (manufacturer: Magventure)
- Keywords
- Transcranial Magnetic Stimulation, Magnetic Resonance Imaging, Neuropsychological Tests, Traumatic Brain Injury, Post-Concussion Syndrome, TMS, Theta-burst, Diffusion magnetic resonance spectroscopy
- Medical subject headings
- Brain Injuries, Traumatic, Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent theta-burst treatment (iTBS) using MagPro Transcranial Magnetic Stimulator (manufacturer: Magventure)Device
Also called transcranial magnetic stimulation (TMS)
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.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist-control-treatment-group | Experimental | After a 2-week control waitlist period, patient receive 30 treatments. Receives: Device: Intermittent theta-burst treatment (iTBS) using MagPro Transcranial Magnetic Stimulator (manufacturer: Magventure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)).
Measured: 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
Neuropsychological test scores (attention measured using Stroop interference test: T scores, 0-100, higher scores indicating better performance; processing speed measured using the Symbol search test, also T-scores). Increase in score means clinical improvement.
Measured: Post-treatment for the individual participant (~4 weeks). Data will be reported at the conclusion of the study for all participants.
Functional outcome
Glasgow Outcome Scale Extended (range 1-8, 1=dead, 8=complete recovery; increase in score means clinical improvement).
Measured: 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
As measured with advanced MRI (e.g., improvement on the multimodal attention task can be reflected by a change in percent signal change in the dorsolateral prefrontal cortices of the executive network, which can be either an increase or decrease).
Measured: Post-treatment for the individual participant (~ 4 weeks). Data will be reported at the conclusion of the study for all participants.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start30 Oct 2023
- Primary completion1 Apr 2025
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group waitlist-control
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Mind Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico
- Responsible party
- Sponsor
- Investigators
- Harm J van der Horn, MD PhD, Principal investigator, Mind Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889117
- Sponsor's protocol ID
- 23-110
- Status last verified
- Mar 2025
- First submitted
- 9 May 2023
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Demographic, clinical, structural MRI, functional MRI, diffusion MRI, and diffusion MRS data will de-identified, linked to a global unique identifier (GUID) and uploaded to The Federal Interagency Traumatic Brain Injury Research (FITBIR) system. These data will be collected on 15 patients with mild traumatic brain injury. All data are exported in industry-specific, but standardized, formats to promote future research endeavors based on FAIR (Findable, Accessible, Interoperable, and Reusable) Data Principles.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurometabolic Effects of Theta-burst Treatment in Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05889117
- Acronym / sponsor ID
- 23-110
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Mind Research NetworkUniversity, hospital or other
- Collaborators
- University of New Mexico
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) seems a promising treatment option for patients with persistent post-concussive symptoms (PPCS). Traditional rTMS sessions are relatively long in duration and can be exhaustive for patients with PPCS. Intermittent theta-burst stimulation (iTBS) is a newer and more rapid form of rTMS, which only takes up to 10 minutes per session. However, little is known about the effects of iTBS in patients with PPCS. Furthermore, there is a pressing need for methods that reliably measure the effects of TMS treatments in-vivo. Using diffusion magnetic resonance spectroscopy (dMRS) changes in neural and glial cell morphology can be quantified, which makes it possible to disentangle neurometabolic changes related to neural injury and neuroinflammation, two key elements in the pathophysiology of mTBI.
In the current study, 15 patients with chronic (>3 months after mTBI) PPCS will undergo a total of 30 iTBS sessions. After a baseline scan, patients will enter a 2-week control waitlist period. Following the waitlist control, a pre-treatment scan is acquired, followed by the stimulation sessions, and final post-treatment scan. The scanning protocol includes T1 and T2 imaging, dMRS, multi-shell diffusion MRI (dMRI), as well as a demanding executive function fMRI task, and resting-state fMRI (rs-fMRI). A comprehensive battery of clinical tests will be administered at all time points, which includes cognitive testing, self-report of symptoms and emotional distress. Long-term outcome is determined three months after start of the study.
Specific study aims are:
Aim 1: To determine the effects of a precision-medicine iTBS guided approach applied to the left dorsolateral prefrontal cortex (DLPFC) on clinical recovery in patients with PPCS relative to waitlist control.
Aim 2: To determine the neurometabolic effects of iTBS in both the left and right DLPFC as measured with dMRS in patients with PPS, and to untangle differential effects on pathophysiological processes (e.g., neural plasticity vs. anti-inflammatory effects).
Aim 3: To determine the relationship of these neurometabolic effects and the integrity of major frontoparietal white matter tracts (as measured with dMRI), as well as activation and functional connectivity of key large-scale cognitive and emotional networks (i.e., executive, default mode, and salience network), measured using task-based and resting-state fMRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group waitlist-control
| Arm | Type | Receives |
|---|---|---|
| Waitlist-control-treatment-group | Experimental | Device: Intermittent theta-burst treatment (iTBS) using MagPro Transcranial Magnetic Stimulator (manufacturer: Magventure)After a 2-week control waitlist period, patient receive 30 treatments. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult age at inclusion 18-64 years.
- 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).
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent theta-burst treatment (iTBS) using MagPro Transcranial Magnetic Stimulator (manufacturer: Magventure)Also: transcranial magnetic stimulation (TMS)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. | Device | Waitlist-control-treatment-group |
Primary outcome
Post-concussive symptoms
Time frame: 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.
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)
Neurometabolite diffusion related to neuronal function and inflammation
Time frame: Post-treatment for the individual participant (~4 weeks). Data will be reported at the conclusion of the study for all participants.
As measured with diffusion MRS (diffusion of neurometabolites computed as the apparent diffusion coefficient (ADC)).
3 secondary outcomes
Cognitive functioning
Time frame: Post-treatment for the individual participant (~4 weeks). Data will be reported at the conclusion of the study for all participants.
Functional outcome
Time frame: 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
Time frame: Post-treatment for the individual participant (~ 4 weeks). Data will be reported at the conclusion of the study for all participants.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Yes. Demographic, clinical, structural MRI, functional MRI, diffusion MRI, and diffusion MRS data will de-identified, linked to a global unique identifier (GUID) and uploaded to The Federal Interagency Traumatic Brain Injury Research (FITBIR) system. These data will be collected on 15 patients with mild traumatic brain injury. All data are exported in industry-specific, but standardized, formats to promote future research endeavors based on FAIR (Findable, Accessible, Interoperable, and Reusable) Data Principles.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harm J van der Horn, MD PhD principal investigator
Mind Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent theta-burst treatment (iTBS) using MagPro Transcranial Magnetic Stimulator (manufacturer: Magventure) in people with Transcranial Magnetic Stimulation and Magnetic Resonance Imaging, run by The Mind Research Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-concussive symptoms (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.