Personalized magnetic brain stimulation for chronic pain
Personalized Pain Treatment by Transcranial Magnetic Stimulation in Patients With Chronic Pain: A Prospective Interventional Study With Embedded Predictive Biomarker Evaluation
NA · Aalborg University · NCT07247552
This trial will try personalized rTMS guided by each person's EEG to see if it reduces pain in adults with chronic pain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Aalborg University (other) |
| Locations | 1 site (Gistrup) |
| Trial ID | NCT07247552 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm interventional proof-of-concept trial using repetitive transcranial magnetic stimulation (rTMS) applied to the primary motor cortex (M1) for adults with chronic pain. Before treatment, participants will have EEG recorded to derive brain connectivity measures that are used to tailor the rTMS parameters for each person. The study tests whether using these neurophysiological biomarkers to personalize stimulation increases the proportion of patients who experience clinically meaningful pain relief compared with historical response rates. Safety and feasibility data will also be collected to inform future randomized efficacy trials.
Who should consider this trial
Good fit: Adults with chronic pain present most days for over 3 months, with average pain rated 3–9/10 and who can speak and understand English or Danish are the intended participants.
Not a fit: People who are pregnant or breastfeeding, have uncontrolled major depression as the main diagnosis, current substance abuse, or formal contraindications to TMS (for example epilepsy or ferromagnetic cranial implants) are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could raise the chance of meaningful pain relief by tailoring rTMS to each patient's brain patterns rather than using the same settings for everyone.
How similar studies have performed: Prior rTMS applied to M1 has produced pain relief in roughly half of patients, but using pre-treatment EEG to personalize stimulation is a newer, largely untested approach in chronic pain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presence of chronic pain (present most of the days for more than 3 months). * Pain with a mean pain intensity between 3-9 on a 0-10 pain scale (where 0 means no pain and 10 means the worst pain imaginable). * Speak and understand English or Danish Exclusion Criteria: * Pregnant or breastfeeding * Current uncontrolled major depression as the main diagnosis * Current history of substance abuse * Lack of ability to cooperate, to fully understand the protocol or any difficulty in filling out questionnaires (e.g., due to language or cognitive problems) * Formal contraindications to TMS application (presence of epilepsy, cranial implanted ferromagnetic devices, e.g., intracranial neurostimulator or cochlear implants, tattoos with metal ink on the face or permanent make up with metal in the face ) * Unable to answer the "Transcranial Magnetic Stimulation Adult Safety Screen" screening questionnaire. * Participation in other research protocols within 1 month before the inclusion.
Where this trial is running
Gistrup
- Aalborg University — Gistrup, Denmark (RECRUITING)
Study contacts
- Principal investigator: Margit M Bach, PhD — Aalborg University
- Study coordinator: Margit M Bach
- Email: forskning.dca@hst.aau.dk
- Phone: +45 9137 3170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Pain, Pain, Neurologic Manifestations, Signs and Symptoms, Pathological Conditions, Signs and Symptoms, Transcranial Magnetic Stimulation, Neuromodulation