Persistent Post Concussive HeadacheNCT06999304
Pilot TMS in Mild TBI
A study testing Intermittent theta burst stimulation in people with Persistent Post Concussive Headache and Mild Traumatic Brain Injury, run by HealthPartners Institute at 1 site in United States.
Trial summary
Persistent post-concussive symptoms (PPCS) involve an array of physical, cognitive, and behavioral symptoms lasting more than a month after mild traumatic brain injury (mTBI). 34-44% of people with mTBI or concussion present with a considerable burden of PPCS 3-6 months after injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Persistent Post Concussive Headache, Mild Traumatic Brain Injury
- What is being tested?
- Intermittent theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2025to Jul 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of mTBI at least 4 weeks prior but not exceeding 12 months prior to the time of screening
- Age 18-65 years at the time of mTBI
- High burden of post concussive symptoms at time of screening, as measured by symptoms questionnaire (PCSS) ≥35*
Who cannot join
- Inability to tolerate imaging; contraindication of imaging due to implants or metal
- Seizure disorder, active alcohol or substance use disorder
- Inability to speak and read English
- Anything else that, in the opinion of the PI/study physician, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
- Subject is pregnant or breast feeding
- Subject has participated in a clinical interventional trial in the last 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130
About this study
Official title: Personalized Accelerated Theta Burst Transcardial Magnetic Stimulation in Mild Traumatic Brain Injury
Persistent post-concussive symptoms (PPCS) involve an array of physical, cognitive, and behavioral symptoms lasting more than a month after mild traumatic brain injury (mTBI). 34-44% of people with mTBI or concussion present with a considerable burden of PPCS 3-6 months after injury. There is currently no standardized treatment for PPCS, nor FDA approved medication for any neuropsychiatric or neurocognitive symptoms associated with mTBI. Transcranial magnetic stimulation (TMS) shows promise as a treatment for PPCS; however, the current one-size-fits-all approach does not address the heterogeneity of symptoms. We propose utilization of resting state functional MRI (rs-fMRI) guided rTMS to target personalized brain networks burdened with PPCS.
- Being tested
- Intermittent theta burst stimulation
- Keywords
- transmagnetic stimulation, functional MRI guided theta burst stimulation, intermittent theta burst stimulation
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent theta burst stimulationDevice
Also called Transmagnetic stimulation, MagVenture
MagVenture TMS Therapy active coil with theta burst stimulation. Resting motor threshold: 80%; Intermittent theta burst - Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz; Continuous theta burst - Number of pulses per session: 1800 pulses; Pulse frequency in burst: 50 Hertz
| Study group | Role | What they receive |
|---|---|---|
| Theta burst stimulation | Experimental | There will be a total of 25 theta burst sessions across 5 treatment visits (5 sessions per treatment visit), over a two-week period. Treatment will be applied to 2 brain regions of interest or parcellations: (1) Left 8AV; 2) A personalized region based on imaging and symptom profile. Receives: Device: Intermittent theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with anomalous parcellations - developing the method of personalization of TMS for PPCS
Percentage of participants matched with anomalous parcellations based on one of the 2 top ranked burdensome symptoms/symptom profile. If an anomalous parcellation matching one of the top 2 ranked symptom profiles can be identified in at least 16 out of 20 (80%) of participants, the trial will be considered a success.
Measured: baseline
Anomalous parcellations - developing the method of personalization of TMS targets for PPCS
Names and number of anomalous parcellations identified using connectivity analysis and targets available to treat with TMS based on symptom profiles
Measured: baseline
Distribution of complaints for PPCS
Distribution of chief symptom/complaints among participants measured by concussion clinical profile (CP) screen
Measured: baseline
Mapping of complaints to anomalous parcellations
Mapping of chief symptom/complaints to parcellations based on literature and connective abnormalities
Measured: baseline
Secondary outcomes (4)
Feasibility - rate of completed treatment
Percent of participants who complete 4 out of the 5 treatment visits.
Measured: 4 weeks
Fidelity
Percent of participants who complete all sessions of treatment.
Measured: 4 weeks
Safety - adverse events
Frequency of each adverse events.
Measured: 16 weeks
Acceptability
This survey will be used to understand the subject's experience with TMS and whether they feel it is an acceptable form of treatment. Questions will be both open-ended and quantitative (Likert scale). In this study, participants will be asked about their level of satisfaction with various aspects of the treatment. This survey is not standardized. Scores presented as percent of subject responses. Range: [0-100]. Higher percentage indicates more acceptability to this form of treatment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start18 Jun 2025
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Post Concussive HeadacheStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bhavani Kashyap, MBBS, PhD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999304
- Sponsor's protocol ID
- A24-141
- Status last verified
- Jul 2026
- First submitted
- 12 May 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No identifiable data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Accelerated Theta Burst Transcardial Magnetic Stimulation in Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06999304
- Acronym / sponsor ID
- A24-141
- Keywords
- transmagnetic stimulation, functional MRI guided theta burst stimulation, intermittent theta burst stimulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 31 May 2025 (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.
Persistent post-concussive symptoms (PPCS) involve an array of physical, cognitive, and behavioral symptoms lasting more than a month after mild traumatic brain injury (mTBI). 34-44% of people with mTBI or concussion present with a considerable burden of PPCS 3-6 months after injury. There is currently no standardized treatment for PPCS, nor FDA approved medication for any neuropsychiatric or neurocognitive symptoms associated with mTBI. Transcranial magnetic stimulation (TMS) shows promise as a treatment for PPCS; however, the current one-size-fits-all approach does not address the heterogeneity of symptoms. We propose utilization of resting state functional MRI (rs-fMRI) guided rTMS to target personalized brain networks burdened with PPCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Theta burst stimulation | Experimental | Device: Intermittent theta burst stimulationThere will be a total of 25 theta burst sessions across 5 treatment visits (5 sessions per treatment visit), over a two-week period. Treatment will be applied to 2 brain regions of interest or parcellations: (1) Left 8AV; 2) A personalized region based on imaging and symptom profile. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of mTBI at least 4 weeks prior but not exceeding 12 months prior to the time of screening
- Age 18-65 years at the time of mTBI
- High burden of post concussive symptoms at time of screening, as measured by symptoms questionnaire (PCSS) ≥35*
Key exclusion criteria (6 listed)
- Inability to tolerate imaging; contraindication of imaging due to implants or metal
- Seizure disorder, active alcohol or substance use disorder
- Inability to speak and read English
- Anything else that, in the opinion of the PI/study physician, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
- Subject is pregnant or breast feeding
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 stimulationAlso: Transmagnetic stimulation, MagVentureMagVenture TMS Therapy active coil with theta burst stimulation. Resting motor threshold: 80%; Intermittent theta burst - Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz; Continuous theta burst - Number of pulses per session: 1800 pulses; Pulse frequency in burst: 50 Hertz | Device | Theta burst stimulation |
Primary outcome
Percentage of participants with anomalous parcellations - developing the method of personalization of TMS for PPCS
Time frame: baseline
Percentage of participants matched with anomalous parcellations based on one of the 2 top ranked burdensome symptoms/symptom profile. If an anomalous parcellation matching one of the top 2 ranked symptom profiles can be identified in at least 16 out of 20 (80%) of participants, the trial will be considered a success.
Anomalous parcellations - developing the method of personalization of TMS targets for PPCS
Time frame: baseline
Names and number of anomalous parcellations identified using connectivity analysis and targets available to treat with TMS based on symptom profiles
Distribution of complaints for PPCS
Time frame: baseline
Distribution of chief symptom/complaints among participants measured by concussion clinical profile (CP) screen
Mapping of complaints to anomalous parcellations
Time frame: baseline
Mapping of chief symptom/complaints to parcellations based on literature and connective abnormalities
4 secondary outcomes
Feasibility - rate of completed treatment
Time frame: 4 weeks
Fidelity
Time frame: 4 weeks
Safety - adverse events
Time frame: 16 weeks
Acceptability
Time frame: 4 weeks
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 22 Jul 2026.
- Individual participant dataSharing planned: No. No identifiable data will be shared with other researchers.
Related trials for Persistent Post Concussive Headache
Recruiting
Effect of Mental Imagery in Patients With Persistent Post-concussion Symptoms
Mild Traumatic Brain Injury, Concussion, Post Concussive Syndrome, Chronic
RecruitingPhase 2
Personalized Brain Stimulation to Treat Chronic Concussive Symptoms
Post-Concussion Syndrome, Concussion, Brain
Active, not recruiting
Mobile Subthreshold Exercise Program for Concussion--R01
Concussion, Brain, Concussion, Mild
Not yet recruiting
SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function.
Persistent Post-concussive Symptoms, Post Traumatic Headache
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.
Bhavani Kashyap, MBBS, PhD principal investigator
HealthPartners Institute
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 stimulation in people with Persistent Post Concussive Headache and Mild Traumatic Brain Injury, run by HealthPartners Institute 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 6 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: enrolling by invitation, as of the sponsor's last update on 22 Jul 2026. 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?
Percentage of participants with anomalous parcellations - developing the method of personalization of TMS for PPCS (time frame: baseline). The study lists 4 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 22 Jul 2026.