Treatment of Peripheral Neuropathic Pain (BrainStim)

  • STATUS
    Recruiting
  • End date
    Feb 1, 2027
  • participants needed
    16
  • sponsor
    Oslo University Hospital
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Updated on 4 October 2022
See if I qualify
chronic pain
polyneuropathy
neuralgia
radiculopathy
peripheral neuropathic pain
nerve damage

Summary

Peripheral neuropathic pain is a disabling chronic pain condition that is difficult to treat. Repetitive transcranial magnetic stimulation (rTMS) to the motor cortex is a treatment method with growing evidence in its ability to alleviate neuropathic pain. This also applies to new deep rTMS coils which permits stimulation of larger cortical areas and with deeper penetration. The aim of this study is to investigate the analgesic efficacy of 5 days of deep rTMS compared to sham stimulation. We will also assess effects of deep rTMS on sleep, psychological fatctors, everyday functioning, and executive functioning.

Details
Condition Neuropathic Pain
Treatment Repetitive transcranial magnetic stimulation
Clinical Study IdentifierNCT05488808
SponsorOslo University Hospital
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

-80 years of age
Peripheral neuropathic pain related to postherpetic neuralgia, peripheral nerve injury, limb amputation, polyneuropathy or radiculopathy, fulfilling the criteria for probable or definite neuropathic pain (Finnerup et al. 2016)
Usual pain intensity at least 4/10 over the past 24 hrs using the numerical scale of the BPI at screening
Daily pain
Pain for at least 3 months
Stable pharmacological treatment for pain or no pharmaceutical treatment at least 1 month prior to inclusion participation
Ability to follow throughout the whole duration of the study

Exclusion Criteria

atients with phantom limb pain after limb amputation
Any clinically significant or unstable medical or psychiatric disorder
Subjects protected by law (guardianship or tutelage measure)
History of or current substance abuse (alcohol, drugs)
Pending litigation
Contraindication to rTMS (past severe head trauma, history of epilepsy or ongoing epilepsy, active cerebral tumour, past neurosurgical intervention, intracranial hypertension, implanted devices not compatible such as cardiac pacemaker and neurostimulator, cochlear implants, pregnancy or lactation. All women of childbearing age will be required to have negative pregnancy test at inclusion and to be using contraception)
Pain conditions more severe than peripheral neuropathic pain
Inability to understand the protocol or to fill out the forms
Other ongoing research protocol or recent past protocol within one month before the inclusion
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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