Personalized rTMS for chronic pain using each person's TMS-EEG brain signals
Building on Previous Evidence: A Mechanistic Clinical Trial of Personalized rTMS for Chronic Pain
This trial will try personalized repetitive transcranial magnetic stimulation (rTMS), picking the brain target from each person's TMS-EEG patterns, to see if it reduces chronic pain in adults who have had pain most days for at least three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Aalborg University Academic / other |
| Locations | 1 site (Gistrup) |
| Trial ID | NCT07266103 on ClinicalTrials.gov |
What this trial studies
The trial enrolls 90 adults with chronic pain and randomizes them 1:1 in a double-blind, two-arm design comparing individualized rTMS target selection versus a standard M1 rTMS protocol. Before treatment, participants undergo TMS-EEG to identify connectivity and alpha-band markers that predict which cortical site (M1, ACC, DLPFC, or posterior insula) is most likely to help. Those in the personalized arm receive rTMS at the site with the highest predicted probability of response, while the control arm receives the standard M1 stimulation. Analgesic outcomes will be compared between groups to determine whether tailoring the stimulation site improves pain relief over the conventional one-size-fits-all approach.
Who should consider this trial
Good fit: Adults with chronic pain present most days for more than 3 months, with average pain of 3–9/10, who can speak and understand English or Danish and have no contraindications to TMS are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, have uncontrolled major depression as the main diagnosis, current substance abuse, epilepsy or implanted ferromagnetic cranial devices, or who cannot cooperate with assessments are unlikely to benefit or will be excluded.
Why it matters
Potential benefit: If successful, personalizing rTMS targets using each patient's brain signals could increase the proportion of patients who achieve meaningful pain relief compared with the current roughly 40% response rate.
How similar studies have performed: Previous rTMS trials have shown benefit for some patients and earlier work identified EEG markers linked to response, but prospective personalized target-selection like this is relatively novel.
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: Enrico De Martino — Aalborg University
- Study coordinator: Enrico De Martino, MD, PhD
- Email: edm@hst.aau.dk
- Phone: +4591811183
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.