RecruitingNot ApplicableNCT06395649

Personalized Treatment by rTMS in Chronic Pain

Personalized Pain Treatment by Transcranial Magnetic Stimulation in Patients With Chronic Pain: a Study on Mechanisms


Sponsor

Aalborg University

Enrollment

90 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • 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 Criteria7

  • 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.
  • Participation in other research protocols within 1 month before the inclusion.

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Interventions

DEVICEClassical rTMS to M1

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.

DEVICErTMS to the High connectivity target

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.

DEVICErTMS to the low connectivity target

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.

DEVICESham rTMS

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.


Locations(1)

Aalborg University

Gistrup, North Denmark, Denmark

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NCT06395649


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