Personalized Treatment by rTMS in Chronic Pain - Study2

NCT07247552 | Recruiting

• 1 other identifier: N-20230076-3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Previous research has shown the effectiveness of magnetic stimulation of the brain as a supplemental treatment for various conditions, such as depression and chronic pain. However, the application of magnetic stimulation has been standardized across patients without considering individual differences. This one-size-fits-all approach results in only half of the patients benefiting from the treatment, with the other half seeing no improvement in their symptoms. Therefore, a study on individuals with chronic pain will be performed to explore how magnetic stimulation treatments can be tailored to each person. This will involve analysing brain signal measurements before the start of the therapy and adjusting/personalizing the magnetic stimulations to each individual person.

Conditions

Chronic Pain

Keywords

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronic Pain; Transcranial Magnetic Stimulation; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Pain intensity (Visual analogue scale)

  The '0' represents 'no pain' at all, and '100' represents the 'worst possible pain' that the individual can imagine.

  VAS will be assessed before treatment and post intervention. Responders are those with ≥30% pain reduction, based on the difference in VAS the last 24 hours at the end of maintenance compared to average pain intensity the week before baseline assessment.

Secondary Outcomes (4)

• Patients' Global Impression of Change

  Patients' Global Impression of Change will be investigated before the treatment, at the end of the course of treatment (8 weeks of treatment), and again after 3 months following the end of treatment.

• Short Brief Pain Inventory

  Short Brief Pain Inventory changes will be investigated before the treatment, at the end of the course of treatment (8 weeks of treatment), and again after 3 months following the end of treatment.

• Short McGill Pain Questionnaire

  Short McGill Pain Questionnaire changes will be investigated before the treatment, at the end of the course of treatment (8 weeks of treatment), and again after 3 months following the end of treatment.

• Quality of sleep (VAS)

  Sleep VAS changes will be investigated before the treatment, at the end of the course of treatment (8 weeks of treatment), and again after 3 months following the end of treatment.

Study Arms (1)

Classical rTMS to M1

ACTIVE COMPARATOR

This is a prospective, single-arm interventional study designed to evaluate the predictive value of a neurophysiological biomarker for rTMS response in chronic pain patients. Patients will be allocated to two groups according to their baseline M1 connectivity at baseline in a 1:1 proportion. Patients with "low" connectivity will be compared to controls having "high" connectivity. All patients will receive repetitive transcranial magnetic stimulation (rTMS) to the primary cortex (M1). Low connectivity will be defined by TMS-EEG evoked responses. Responses to a single pulse of TMS delivered to M1 before therapy. TMS-EEG responses will be analysed by phase- and power-based metrics such as global mean field power and inter-trial coherence in the alpha band, according to previous studies. The study main hypothesis is that pre-therapy M1 low connectivity is a predictor of response to M1 rTMS.

Device: rTMS to M1

Interventions

rTMS to M1 DEVICE

• The rTMS intervention consists of 10-Hz rTMS. Thirty trains of ten seconds with an interval of twenty seconds between trains will be delivered, as traditionally performed. Each train includes 100 pulses, and the total number of pulses will be 3,000 given in 15 minutes. All patients will receive 14 sessions of rTMS.

Classical rTMS to M1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Gistrup, 9260, Denmark

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Margit M Bach, PhD

  Aalborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margit M Bach

CONTACT

+45 9137 3170; forskning.dca@hst.aau.dk

Daniel C de Andrade

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients and investigators are blinded to the prediction of whether a participant is expected to become a responder or non-responder.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: April 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)