Personalized Treatment by rTMS in Chronic Pain

NCT06395649 | Recruiting

• 1 other identifier: N-20230076
• 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 analyzing brain signal measurements before the start of the therapy and adjusting/personalizing the magnetic stimulations to each individual person.

Conditions

Chronic Pain

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, 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 (5)

• 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.

• Short McGill Pain Questionnaire

  Short McGill Pain Questionnaire 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, immediately after 2 months of treatment, and again after 3 months of treatment.

Study Arms (4)

Classical rTMS to M1x

ACTIVE COMPARATOR

The patients will receive repetitive transcranial magnetic stimulation (rTMS) to the primary cortex (M1) according to the classical treatment.

Device: Classical rTMS to M1

High connectivity target

EXPERIMENTAL

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

Device: rTMS to the High connectivity target

Low connectivity target

EXPERIMENTAL

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

Device: rTMS to the low connectivity target

Sham stimulation

SHAM COMPARATOR

Subjects experiencing significant pain reduction (according to the primary outcome) by the treatment will be asked if they would like to continue maintenance stimulation sessions. Participants accepted to join this part of the study will receive 1 stimulation session every 2 weeks for 4 weeks (total of 2 stimulation sessions). The participants will receive either active stimulation exactly as they received previously or sham stimulation with rTMS in a double-blind, randomized, placebo-controlled, two-group setup.

Device: Sham rTMS

Interventions

Classical 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.

Classical rTMS to M1x

rTMS to the High connectivity target 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 target, showing the highest connectivity.

High connectivity target

rTMS to the low connectivity target 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. 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 target, showing the lowest connectivity.

Low connectivity target

Sham rTMS DEVICE

Sham stimulation was carried out with a sham coil of identical size, color, and shape, emitting a sound similar to that emitted by the active coil.

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 75 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 )16
• Unable to answer the "Transcranial Magnetic Stimulation Adult Safety Screen" screening questionnaire.

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Gistrup, North Denmark, 9260, Denmark

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Enrico De Martino, Dr

  Aalborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico De Martino, Dr

CONTACT

91811183; edm@hst.aau.dk

Daniel Ciampi de Andrade, Prof

CONTACT

dca@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• 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: April 29, 2024
• First Posted: May 2, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)