Post-Traumatic HeadacheNCT05857761
GAIN Symptoms: Post-traumatic Headache
A study testing Active repetitive transcranial magnetic stimulation (rTMS) in people with Post-Traumatic Headache and Concussion, Mild, run by University of Aarhus at 1 site in Denmark.
Trial summary
The overall aim of the study is to advance the knowledge on the characterization and underlying pathophysiological mechanisms of persistent post-traumatic headache (PTH) with a direct impact on the ability to diagnose and manage PTH effectively. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Headache, Concussion, Mild, MTBI - Mild Traumatic Brain Injury
- What is being tested?
- Active repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Aug 2023to 31 Dec 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- mTBI within the last 2 to 4 months according to the diagnostic criteria recommended by the WHO task force
- age ≥ 18 years at the time of mTBI
- Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score ≥ 3 (moderate or severe problem) for subitem headache and a diagnosis of persistent PTH attributed to mTBI according to ICHD-3.
- Additionally, for study 2 and 3, subjects have to be stable on preventative headache medication. However, subjects are permitted to take ''as needed'' (PRN) medications throughout the study with documentation in a daily headache diary.
Who cannot join
- objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage
- previous mTBI within the last 2 years years leading to PCS lasting ≥ 3 months. Additionally, for study 2 and 3,
- Pre-trauma headache frequency ≥ 10 days in average per month the last 3 months prior to mTBI.
- past history of TMS therapy or TMS-related contraindications (pacemaker, epilepsy etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-traumatic Headache: Phenotyping and Exploring Pathophysiological Insights and Novel Treatment Strategies
The overall aim of the study is to advance the knowledge on the characterization and underlying pathophysiological mechanisms of persistent post-traumatic headache (PTH) with a direct impact on the ability to diagnose and manage PTH effectively. The investigators also aim to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS), a novel intervention on PTH.
Read the detailed description
Post-traumatic headache (PTH) is one of the most common and persistent symptoms following mild traumatic brain injury (mTBI), with an estimation of 18-22% developing persistent (> 3 months) PTH. PTH is highly disabling. Unfortunately, its typical characteristics and pathophysiology are poorly understood leading to its complicated and diverse management.
There is no agreement on the clinical presentation of PTH.This is largely due to the scarcity of longitudinal prospective data on large cohorts of PTH. Describing headache phenotypes longitudinally might improve disease characterization, facilitate better classification and provide evidence based-criteria of diagnosing PTH. Furthermore, exploring biomarkers associated with mTBI may provide new knowledge on the poorly understood pathophysiology of post commotional symptoms (PCS) and PTH. Additionally, there are indications of somatosensory disturbances and impaired endogenous analgesic systems in PTH patients. Assessment of somatosensory signs and symptoms in relation to pain complaints and functioning of endogenous analgesic system may also aid in better understanding of pain mechanisms in these patients. Functioning of endogenous analgesic system can be assessed using conditioned pain modulation (CPM) paradigms. Further, a curious observation in concussion patients with face and/or head pain is that they perceive painful/affected area (head and/or face region) as "swollen" or "different" without any clinical signs or obvious physical differences. Hence, such "illusions" represent body image distortions or perceptual distortion (PD) of the head or face region, and may contribute to the chronification of pain. PD can significantly affect psychosocial well-being of patients as the face/head region is a key feature of one´s identity. Unfortunately, such a distressing phenomenon has not been investigated before in these patients. Currently, no strong evidence-based treatment guidelines for PTH exist. Neuromodulation using repetitive transcranial magnetic stimulation (rTMS) targeting involved brain regions and functional networks has recently been employed to treat several chronic pain conditions including migraine. Thus, rTMS could offer an optimal new treatment strategy for PTH, as there is an evidence of brain network dysfunction in these patients.
The overall aim is to advance the knowledge on the characterization and underlying pathophysiological mechanisms of persistent PTH. The aim is also to measure the prevalence of perceived size changes (PD) of head and/or face region in patients with mild traumatic brain injury and its association with pain/PTH and other post commotional symptoms (PCS). The investigators will also evaluate the efficacy of rTMS on PTH. Deep phenotyping of PTH will be performed. Blood samples from mTBI patients will be examined for the biomarkers of PCS and PTH and the association between the biomarkers and the symptom levels of PCS, in particular PTH frequency and intensity will be evaluated. Baseline biomarker levels in the blood samples from patients with mTBI will be compared to biomarker levels in blood samples from anonymous healthy age- and sex matched controls (blood donors) or published reference intervals from the litterature. Additionally, the association between somatosensory function including CPM and the PTH frequency and intensity will be examined. Further, the effect of rTMS on headache severity and frequency (primary outcome) and somatosensory function, PD and other PCS (secondary outcome) after 1 and 3 months of stimulation will be evaluated.
- Being tested
- Active repetitive transcranial magnetic stimulation (rTMS), Sham repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- Post-traumatic headache, Concussion, Mild Traumatic Brain Injury
- Medical subject headings
- Post-Traumatic Headache, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active repetitive transcranial magnetic stimulation (rTMS)Device
Five sessions of active rTMS therapy will be distributed over 2 weeks (20 Hz, 2000 pulses, 90% resting motor threshold) will be delivered to left dorsolateral pre-frontal cortex (DLPFC) around 6 months post-trauma.
Sham repetitive transcranial magnetic stimulation (rTMS)Device
Five sessions of sham rTMS therapy will be distributed over 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sham group | Sham comparator | participants (n=31) will receive sham rTMS. Receives: Device: Sham repetitive transcranial magnetic stimulation (rTMS) |
| Active rTMS treatment | Active comparator | Participants (n=31) will receive active rTMS treatment. Receives: Device: Active repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of headache days of moderate to severe intensity
Change in the number of headache days of moderate to severe intensity from baseline to 1-month post intervention based on a self-reported daily headache diary, a self-reported headache questionaire and Headache Impact test (HIT-6).
Measured: Prior to intervention compared to 1 month after end of treatment.
Changes in the concentration of biomarkers
Changes in the blood biomarkers (such as neurofilament light chain, calcitonin gene related peptide, pituitary adenylate cyclase-activating polypeptide, cytokines, mRNA, microRNA and circular RNA) and somatosensory function from baseline to immediately after the completion of intervention (rTMS) and 1 month post-rTMS. Associations between total symptomload (Total RPQ score) and blood biomarker concentrations will be investigated.
Measured: Prior to rTMS intervention, immediately after rTMS intervention and 1 month after end of treatment
A comparison at baseline of the blood biomarker concentrations in the mTBI patients compared to healthy controls
Differences in the blood biomarkers (such as neurofilament light chain, calcitonin gene related peptide, pituitary adenylate cyclase-activating polypeptide, cytokines, mRNA, microRNA and circular RNA) at baseline.
Measured: Prior to rTMS intervention
Characterization of PTH headache phenotypes using a self-constructed headache questionaire.
Characterization of PTH headache phenotypes into e.g. migraine-like or tension-type like using a self-constructed headache questionnaire.
Measured: 3 months after mTBI
Secondary outcomes (15)
Change in the number of headache days of moderate to severe intensity
Change in the number of headache days of moderate to severe intensity from baseline to 1-month post intervention based on a self-reported daily headache diary, a self-reported headache questionaire and Headache Impact test (HIT-6).
Measured: Prior to intervention compared to 3 months after end of treatment.
Change in severity of post-concussion symptoms covering physical, cognitive, and emotional symptoms.
Will be measured using the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) [range 0-64 (worst)].
Measured: Prior to intervention compared to 1 and 3 months after end of treatment
Change in the use of medication, non-pharmacological treatment and management strategies.
Will be measured using a self-constructed, self-reported questionaire
Measured: Prior to intervention compared to 1 and 3 months after end of treatment
Change in health-related quality of life
Will be measured using the EuroQol-5 Domain (EQ-5D-5L) [5 items, range 0-100. 100 means the best health you can imagine]
Measured: Prior to intervention compared to 1 and 3 months after end of treatment
Change in self-reported impact on participation and autonomy
Will be measured using the Impact on Participation and Autonomy questionaire (IPAQ-DK). IPAQ DK consists of 32 items which can be answered from 0-4. Higher score corresponds to less participation and autonomy.
Measured: Prior to intervention compared to 1 and 3 months after end of treatment.
Change in Psychological Distress
Will be measured using the Screening for Anxiety and depression (SCL-13). SCL-13 consists of 13 items from the Symptom Check List-90. Each item can be ranged from 0-4 (not at all- very much). A high score corresponds to a high level of depressive and/or anxiety symptoms.
Measured: Prior to intervention compared to 1 and 3 months after end of treatment.
Change in illness perception
Will be measured using the The Brief Illness Perception Questionnaire (B-IPQ). B-IPQ consists of 9 items. Each item is rated on a 0-10 scale, with higher scores indicating a more threatening perception of the illness. The total score is calculated by summing the scores of all eight items, with a possible range of 0-80. Higher scores indicate worse illness perception.
Measured: Prior to intervention compared to 1 and 3 months after end of treatment
Change in Pain Catastrophizing
Will be measured using the Pain Catastrophizing Scale (PCS-DK). Consists of 13 items. Each item is ranged from 0-4. A high score corresponds to a high degree of pain catastrophizing.
Measured: Prior to intervention compared to 1 and 3 months after end of treatment
Change in facial perception
Will be measured using a self-constructed, self-reported questionaire
Measured: Prior to intervention compared to 1 and 3 months after end of treatment
Change in self-reported efficacy of treatment
Will be measured using Patients Global Impression of Change (PGIC-DK). 1 item ranged 0-6. A high score corresponds to a subjective improvement.
Measured: Prior to intervention compared to 1 and 3 months after end of treatment
Change in how neck pain affects daily life
Will be measured using the Neck Pain Disability Index (NDI-DK). 8 items ranged 0-6. A high score corresponds to a high impact on daily life.
Measured: Prior to intervention compared to 1 and 3 months after end of treatment
Changes in sleep quality
Will be measured using the Pittsburgh Sleep Quality Index (PSQI-DK). seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: Prior to intervention compared to 1 and 3 months after end of treatment
Changes in the somatosensory function.
Change in the somatosensory function from baseline to immediately after the completion of intervention (rTMS) and 1 month post-rTMS.
Measured: prior to rTMS intervention, immediately after rTMS intervention and 1 month after end of treatment
Changes in headache impact measured on the Headache Impact Scale.
Headache Impact Scale (HIT-6). HIT-6 is a 6 item scale. Each item is ranged from 0-5 ("never-always"). A high total score corresponds to a high impact of the headache on daily functioning.
Measured: baseline, 1 months after end of treatment, 3 months after end of treatment
Changes in headache phenotype using a self-constructed headache questionaire.
Describing changes in the headache phenotype (e.g. migraine-like or tension-type like) longitudinally using a self-constructed headache questionnaire.
Measured: 3, 9 and 12 months after mTBI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start28 Aug 2023
- Primary completion31 Aug 2024
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention study will be conducted as a randomized, sham-controlled, parallel group clinical trial consisting of an active (n=31) and a sham group (n=31).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Hammel Neurorehabilitation Centre and University Research Clinic, Central Denmark Region
- Responsible party
- Principal investigator, Charlotte Nygaard, Regionshospitalet Hammel Neurocenter
- Investigators
- Jørgen Feldbæk Nielsen, Proffessor, Study director, Research Unit Hammel Neurocenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857761
- Sponsor's protocol ID
- GAIN: Post-traumatic Headache
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ebener M, Hasselhorn HM. Validation of Short Measures of Work Ability for Research and Employee Surveys. Int J Environ Res Public Health. 2019 Sep 12;16(18):3386. doi: 10.3390/ijerph16183386.
PubMed 31547466Mollica A, Safavifar F, Fralick M, Giacobbe P, Lipsman N, Burke MJ. Transcranial Magnetic Stimulation for the Treatment of Concussion: A Systematic Review. Neuromodulation. 2021 Jul;24(5):803-812. doi: 10.1111/ner.13319. Epub 2020 Nov 12.
PubMed 33184973
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-traumatic Headache: Phenotyping and Exploring Pathophysiological Insights and Novel Treatment Strategies
- ClinicalTrials.gov ID
- NCT05857761
- Acronym / sponsor ID
- GAIN: Post-traumatic Headache
- Keywords
- Post-traumatic headache, Concussion, Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Hammel Neurorehabilitation Centre and University Research Clinic, Central Denmark Region
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 May 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 overall aim of the study is to advance the knowledge on the characterization and underlying pathophysiological mechanisms of persistent post-traumatic headache (PTH) with a direct impact on the ability to diagnose and manage PTH effectively. The investigators also aim to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS), a novel intervention on PTH.
Detailed description
Post-traumatic headache (PTH) is one of the most common and persistent symptoms following mild traumatic brain injury (mTBI), with an estimation of 18-22% developing persistent (> 3 months) PTH. PTH is highly disabling. Unfortunately, its typical characteristics and pathophysiology are poorly understood leading to its complicated and diverse management.
There is no agreement on the clinical presentation of PTH.This is largely due to the scarcity of longitudinal prospective data on large cohorts of PTH. Describing headache phenotypes longitudinally might improve disease characterization, facilitate better classification and provide evidence based-criteria of diagnosing PTH. Furthermore, exploring biomarkers associated with mTBI may provide new knowledge on the poorly understood pathophysiology of post commotional symptoms (PCS) and PTH. Additionally, there are indications of somatosensory disturbances and impaired endogenous analgesic systems in PTH patients. Assessment of somatosensory signs and symptoms in relation to pain complaints and functioning of endogenous analgesic system may also aid in better understanding of pain mechanisms in these patients. Functioning of endogenous analgesic system can be assessed using conditioned pain modulation (CPM) paradigms. Further, a curious observation in concussion patients with face and/or head pain is that they perceive painful/affected area (head and/or face region) as "swollen" or "different" without any clinical signs or obvious physical differences. Hence, such "illusions" represent body image distortions or perceptual distortion (PD) of the head or face region, and may contribute to the chronification of pain. PD can significantly affect psychosocial well-being of patients as the face/head region is a key feature of one´s identity. Unfortunately, such a distressing phenomenon has not been investigated before in these patients. Currently, no strong evidence-based treatment guidelines for PTH exist. Neuromodulation using repetitive transcranial magnetic stimulation (rTMS) targeting involved brain regions and functional networks has recently been employed to treat several chronic pain conditions including migraine. Thus, rTMS could offer an optimal new treatment strategy for PTH, as there is an evidence of brain network dysfunction in these patients.
The overall aim is to advance the knowledge on the characterization and underlying pathophysiological mechanisms of persistent PTH. The aim is also to measure the prevalence of perceived size changes (PD) of head and/or face region in patients with mild traumatic brain injury and its association with pain/PTH and other post commotional symptoms (PCS). The investigators will also evaluate the efficacy of rTMS on PTH. Deep phenotyping of PTH will be performed. Blood samples from mTBI patients will be examined for the biomarkers of PCS and PTH and the association between the biomarkers and the symptom levels of PCS, in particular PTH frequency and intensity will be evaluated. Baseline biomarker levels in the blood samples from patients with mTBI will be compared to biomarker levels in blood samples from anonymous healthy age- and sex matched controls (blood donors) or published reference intervals from the litterature. Additionally, the association between somatosensory function including CPM and the PTH frequency and intensity will be examined. Further, the effect of rTMS on headache severity and frequency (primary outcome) and somatosensory function, PD and other PCS (secondary outcome) after 1 and 3 months of stimulation will be evaluated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The intervention study will be conducted as a randomized, sham-controlled, parallel group clinical trial consisting of an active (n=31) and a sham group (n=31).
| Arm | Type | Receives |
|---|---|---|
| Sham group | Sham comparator | Device: Sham repetitive transcranial magnetic stimulation (rTMS)participants (n=31) will receive sham rTMS. |
| Active rTMS treatment | Active comparator | Device: Active repetitive transcranial magnetic stimulation (rTMS)Participants (n=31) will receive active rTMS treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- mTBI within the last 2 to 4 months according to the diagnostic criteria recommended by the WHO task force
- age ≥ 18 years at the time of mTBI
- Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score ≥ 3 (moderate or severe problem) for subitem headache and a diagnosis of persistent PTH attributed to mTBI according to ICHD-3.
- Additionally, for study 2 and 3, subjects have to be stable on preventative headache medication. However, subjects are permitted to take ''as needed'' (PRN) medications throughout the study with documentation in a daily headache diary.
Key exclusion criteria (4 listed)
- objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage
- previous mTBI within the last 2 years years leading to PCS lasting ≥ 3 months. Additionally, for study 2 and 3,
- Pre-trauma headache frequency ≥ 10 days in average per month the last 3 months prior to mTBI.
- past history of TMS therapy or TMS-related contraindications (pacemaker, epilepsy etc.).
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 |
|---|---|---|
| Active repetitive transcranial magnetic stimulation (rTMS)Five sessions of active rTMS therapy will be distributed over 2 weeks (20 Hz, 2000 pulses, 90% resting motor threshold) will be delivered to left dorsolateral pre-frontal cortex (DLPFC) around 6 months post-trauma. | Device | Active rTMS treatment |
| Sham repetitive transcranial magnetic stimulation (rTMS)Five sessions of sham rTMS therapy will be distributed over 2 weeks | Device | Sham group |
Primary outcome
Change in the number of headache days of moderate to severe intensity
Time frame: Prior to intervention compared to 1 month after end of treatment.
Change in the number of headache days of moderate to severe intensity from baseline to 1-month post intervention based on a self-reported daily headache diary, a self-reported headache questionaire and Headache Impact test (HIT-6).
Changes in the concentration of biomarkers
Time frame: Prior to rTMS intervention, immediately after rTMS intervention and 1 month after end of treatment
Changes in the blood biomarkers (such as neurofilament light chain, calcitonin gene related peptide, pituitary adenylate cyclase-activating polypeptide, cytokines, mRNA, microRNA and circular RNA) and somatosensory function from baseline to immediately after the completion of intervention (rTMS) and 1 month post-rTMS. Associations between total symptomload (Total RPQ score) and blood biomarker concentrations will be investigated.
A comparison at baseline of the blood biomarker concentrations in the mTBI patients compared to healthy controls
Time frame: Prior to rTMS intervention
Differences in the blood biomarkers (such as neurofilament light chain, calcitonin gene related peptide, pituitary adenylate cyclase-activating polypeptide, cytokines, mRNA, microRNA and circular RNA) at baseline.
Characterization of PTH headache phenotypes using a self-constructed headache questionaire.
Time frame: 3 months after mTBI
Characterization of PTH headache phenotypes into e.g. migraine-like or tension-type like using a self-constructed headache questionnaire.
15 secondary outcomes
Change in the number of headache days of moderate to severe intensity
Time frame: Prior to intervention compared to 3 months after end of treatment.
Change in severity of post-concussion symptoms covering physical, cognitive, and emotional symptoms.
Time frame: Prior to intervention compared to 1 and 3 months after end of treatment
Change in the use of medication, non-pharmacological treatment and management strategies.
Time frame: Prior to intervention compared to 1 and 3 months after end of treatment
Change in health-related quality of life
Time frame: Prior to intervention compared to 1 and 3 months after end of treatment
Change in self-reported impact on participation and autonomy
Time frame: Prior to intervention compared to 1 and 3 months after end of treatment.
Change in Psychological Distress
Time frame: Prior to intervention compared to 1 and 3 months after end of treatment.
Change in illness perception
Time frame: Prior to intervention compared to 1 and 3 months after end of treatment
Change in Pain Catastrophizing
Time frame: Prior to intervention compared to 1 and 3 months after end of treatment
Change in facial perception
Time frame: Prior to intervention compared to 1 and 3 months after end of treatment
Change in self-reported efficacy of treatment
Time frame: Prior to intervention compared to 1 and 3 months after end of treatment
Change in how neck pain affects daily life
Time frame: Prior to intervention compared to 1 and 3 months after end of treatment
Changes in sleep quality
Time frame: Prior to intervention compared to 1 and 3 months after end of treatment
Changes in the somatosensory function.
Time frame: prior to rTMS intervention, immediately after rTMS intervention and 1 month after end of treatment
Changes in headache impact measured on the Headache Impact Scale.
Time frame: baseline, 1 months after end of treatment, 3 months after end of treatment
Changes in headache phenotype using a self-constructed headache questionaire.
Time frame: 3, 9 and 12 months after mTBI
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 1 May 2026.
- Background: PubMed 31547466Ebener M, Hasselhorn HM. Validation of Short Measures of Work Ability for Research and Employee Surveys. Int J Environ Res Public Health. 2019 Sep 12;16(18):3386. doi: 10.3390/ijerph16183386.
- Background: PubMed 33184973Mollica A, Safavifar F, Fralick M, Giacobbe P, Lipsman N, Burke MJ. Transcranial Magnetic Stimulation for the Treatment of Concussion: A Systematic Review. Neuromodulation. 2021 Jul;24(5):803-812. doi: 10.1111/ner.13319. Epub 2020 Nov 12.
- Individual participant dataSharing planned: No
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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.
Jørgen Feldbæk Nielsen, Proffessor study director
Research Unit Hammel Neurocenter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active repetitive transcranial magnetic stimulation (rTMS) in people with Post-Traumatic Headache and Concussion, Mild, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 4 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 1 May 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Change in the number of headache days of moderate to severe intensity (time frame: Prior to intervention compared to 1 month after end of treatment.). 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?
On the ClinicalTrials.gov record for NCT05857761, which also lists 2 linked publications.
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 1 May 2026.