Treatment of Peripheral Neuropathic Pain

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

Sponsors

Lead Sponsor: Oslo University Hospital

Source Oslo University Hospital
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.

Overall Status Recruiting
Start Date 2022-02-01
Completion Date 2027-02-01
Primary Completion Date 2027-02-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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 (one week before treatment) and 1 week after the last stimulation. Measurement ends 3 weeks after last stimulation]
Secondary Outcome
Measure Time Frame
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 intensity over the last 24 hours Baseline, 1 week and 3 weeks after the end of each stimulation period
Pain unpleasantness during the last 24 hours Baseline, 1 week and 3 weeks after the end of each stimulation period
Intensity of dynamic mechanical allodynia 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
Proportion of responders 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
Hospital Anxiety and Depression Scale 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
Patient Global Impression of Change 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
Blinding 3 weeks after the end of each stimulation period
Enrollment 16
Condition
Intervention

Intervention Type: Device

Intervention Name: repetitive Transcranial Magnetic Stimulation

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 leg.

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

18 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Audun Stubhaug, MD, PhD Study Director OUS
Overall Contact

Last Name: Nadine Farnes, MSc

Phone: 45243835

Phone Ext.: 0047

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Department of Pain Management and Research, Oslo University Hospital and Faculty of Medicine, University of Oslo, Audun Stubhaug, PhD [email protected]),
Location Countries

Norway

Verification Date

2022-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Oslo University Hospital

Investigator Full Name: Nadine Farnes

Investigator Title: Ph.D. student

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Active and then sham rTMS

Type: Active Comparator

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.

Label: Sham and the active rTMS

Type: Sham Comparator

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.

Acronym BrainStim
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

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

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: Blinding is achieved by inserting a card into the rTMS stimulator which determines whether the patient receives active or sham stimulation, making both participant and investigator blind towards group allocation. Care providers are also blinded to treatment allocation. Main efficacy analyses will be performed blinded without identification of participants and group allocation.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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