Deep Repetitive Transcranial Magnetic Stimulation for Peripheral Neuropathic Pain. A Randomized Double-blind Sham-controlled Study.

Oslo University Hospital1 site in 1 country17 target enrollmentFebruary 1, 2022

ConditionsNeuropathic Pain

Overview

Phase: N/A
Intervention: Not specified
Conditions: Neuropathic Pain
Sponsor: Oslo University Hospital
Enrollment: 17
Locations: 1
Primary Endpoint: Usual pain intensity over the past 24 hours
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 1, 2022

End Date

November 24, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Oslo University Hospital

Responsible Party

Principal Investigator

Nadine Farnes

Ph.D. student

Oslo University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Usual pain intensity over the past 24 hours

Time Frame: Analgesic efficacy of active and sham treatment is measured as the change in pain intensity scores between baseline values (one week before treatment) and 1 week after the last stimulation. Measurement ends 3 weeks after last stimulation]

Measured every day in a diary at the same hour (end of the day) on an 11-point NRS (0 = no pain, 10 = worst pain intensity imaginable of the current pain condition)

Secondary Outcomes

Intensity of dynamic mechanical allodynia(Baseline, 1 week and 3 weeks after the end of each stimulation period)
Pain intensity over the last 24 hours(Baseline, 1 week and 3 weeks after the end of each stimulation period)
Patient Global Impression of Change(Baseline,1 week and 3 weeks after the end of each stimulation period)
Blinding(3 weeks after the end of each stimulation period)
Usual pain intensity over the past 24 hours(Analgesic efficacy of active and sham treatment is measured as the change in pain intensity scores between baseline values and 3 weeks after the last stimulation)
Pain unpleasantness during the last 24 hours(Baseline, 1 week and 3 weeks after the end of each stimulation period)
Proportion of responders(Baseline,1 week and 3 weeks after the end of each stimulation period])
Hospital Anxiety and Depression Scale(Baseline,1 week and 3 weeks after the end of each stimulation period)
Intensity of static mechanical allodynia(Baseline, 1 week and 3 weeks after the end of each stimulation period)
Percentage pain intensity reduction(Baseline,1 week and 3 weeks after the end of each stimulation period)
Pain Catastrophizing Scale(Baseline,1 week and 3 weeks after the end of each stimulation period)
Insomnia Severity Index(Baseline,1 week and 3 weeks after the end of each stimulation period)
Patient-Specific Functional Scale(Baseline,1 week and 3 weeks after the end of each stimulation period)
Executive functioning using the CANTAB battery(Baseline,1 week and 3 weeks after the end of each stimulation period)
Side-effects(Immediately after the first rTMS session for both stimulation periods and 1 week and 3 weeks after each stimulation period)