Treatment of Peripheral Neuropathic Pain (BrainStim)

University of Oslo (UIO)

Status: Completed

Conditions: Neuropathic Pain

Treatments: Device: repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05488808

428116

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-80 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups

Active and then sham rTMS

Active Comparator group

Description:

Deep rTMS is delivered with the Brainsway H7-coil (Brainsway, Jerusalem, Israel) applied via a helmet placed on the head targeting the primary motor cortex of the arm.

Treatment:

Device: repetitive Transcranial Magnetic Stimulation

Sham and the active rTMS

Sham Comparator group

Description:

Sham stimulation is delivered with a sham coil placed in the helmet encasing the active rTMS coil. Sham rTMS sessions will use exactly the same parameters of stimulation as active rTMS.

Treatment:

Device: repetitive Transcranial Magnetic Stimulation