Mechanistic Study of Personalized rTMS in Chronic Pain

NCT07266103 | Not Yet Recruiting DMC

• 1 other identifier: N-20230076-4
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Previous research has demonstrated that repetitive magnetic brain stimulation can be an effective adjunctive treatment for several conditions, including chronic pain. However, current stimulation protocols are typically standardized and do not account for individual variability in brain function. This uniform, one-size-fits-all approach results in only about 40% of patients experiencing meaningful clinical benefit, while the remainder show little to no improvement. To address this limitation, the present study will investigate how magnetic stimulation can be tailored to individuals with chronic pain. By analyzing each participant's brain signals prior to treatment, we aim to personalize stimulation parameters to better match individual neural characteristics and potentially enhance therapeutic outcomes. The design of this study builds directly on the findings of a previous clinical trial.

Conditions

Chronic Pain

Keywords

pain; TMS-EEG; rTMS

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.

  Visual analogue scale will be assessed before treatment, after 2 months, and again after 3 months. Responders are those with ≥30% pain reduction at the end of maintenance compared to average pain intensity the week before baseline assessment.

Secondary Outcomes (4)

• Quality of life (EQ-5D)

  Quality of life changes will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment.

• Patients' Global Impression of Change

  Patients' Global Impression of Change will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment

• Short Brief Pain Inventory

  Short Brief Pain Inventory changes will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment.

• Connectivity analysis

  Connectivity changes will be investigated before the treatment and immediately after 2 months of treatment.

Study Arms (2)

Active Comparator : Classical rTMS

ACTIVE COMPARATOR

The patients will receive repetitive transcranial magnetic stimulation according to the classical treatment

Device: Classical repetitive trancranial magnetic stimulation to M1

Experimental: Personalized Target Arm

EXPERIMENTAL

The patients will receive repetitive transcranial magnetic stimulation (rTMS) to target showing the optimal connectivity during the TMS-EEG assessment one week before starting the treatment

Device: Personalized Target Arm

Interventions

Personalized Target Arm DEVICE

The rTMS intervention consists of 10-Hz rTMS. Thirty trains of ten seconds will be delivered with an interval of twenty seconds between trains. Each train includes 100 pulses, and the total number of pulses will be 3,000 given in 15 minutes. The rTMS will be delivered to the optimal target

Experimental: Personalized Target Arm

Classical repetitive trancranial magnetic stimulation 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.

Active Comparator : Classical rTMS

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

MeSH Terms

Conditions

Chronic Pain; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Enrico De Martino

  Aalborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico De Martino, MD, PhD

CONTACT

+4591811183; edm@hst.aau.dk

Daniel Ciampi De Andrade, MD, PhD

CONTACT

dca@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: When 50% of inclusion is completed, a preplanned interim futility analysis is scheduled to examine safety and the main outcome.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 5, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share