Clinical trial NCT05488808: Treatment of Peripheral Neuropathic Pain
Official title: Deep Repetitive Transcranial Magnetic Stimulation for Peripheral Neuropathic Pain. A Randomized Double-blind Sham-controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Keywords: Repetitive Transcranial Magnetic Stimulation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients undergo stimulation with deep rTMS in a double blinded randomised controlled trial (RCT) with a 2 x 2 cross-over design, receiving both active and placebo stimulation. Patients are randomly assigned in a 1:1 ration to one of two counterbalanced arms: either they first receive active rTMS and then sham rTMS after a 9 week washout period, or the first receive sham rTMS and then active rTMS after 9 weeks of washout.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Usual pain intensity over the past 24 hours
timeFrame: 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]
Secondary outcomes:
measure: Usual pain intensity over the past 24 hours
timeFrame: 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
measure: Pain intensity over the last 24 hours
timeFrame: Baseline, 1 week and 3 weeks after the end of each stimulation period
measure: Pain unpleasantness during the last 24 hours
timeFrame: Baseline, 1 week and 3 weeks after the end of each stimulation period
measure: Intensity of dynamic mechanical allodynia
timeFrame: Baseline, 1 week and 3 weeks after the end of each stimulation period
measure: Intensity of static mechanical allodynia
timeFrame: Baseline, 1 week and 3 weeks after the end of each stimulation period
measure: Proportion of responders
timeFrame: Baseline,1 week and 3 weeks after the end of each stimulation period]
measure: Percentage pain intensity reduction
timeFrame: Baseline,1 week and 3 weeks after the end of each stimulation period
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline,1 week and 3 weeks after the end of each stimulation period
measure: Pain Catastrophizing Scale
timeFrame: Baseline,1 week and 3 weeks after the end of each stimulation period
measure: Patient Global Impression of Change
timeFrame: Baseline,1 week and 3 weeks after the end of each stimulation period
measure: Insomnia Severity Index
timeFrame: Baseline,1 week and 3 weeks after the end of each stimulation period
measure: Patient-Specific Functional Scale
timeFrame: Baseline,1 week and 3 weeks after the end of each stimulation period
measure: Executive functioning using the CANTAB battery
timeFrame: Baseline,1 week and 3 weeks after the end of each stimulation period
measure: Side-effects
timeFrame: Immediately after the first rTMS session for both stimulation periods and 1 week and 3 weeks after each stimulation period
measure: Blinding
timeFrame: 3 weeks after the end of each stimulation period
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Pain Management and Research, Oslo University Hospital and Faculty of Medicine, University of Oslo,
Study officials:
affiliation: OUS
name: Audun Stubhaug, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492.