Treatment of Peripheral Neuropathic Pain

NCT05488808 | Completed

• 1 other identifier: 428116
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Keywords

Repetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Usual pain intensity over the past 24 hours

  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)

  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 (15)

• 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

Study Arms (2)

Active and then sham rTMS

ACTIVE COMPARATOR

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.

Device: repetitive Transcranial Magnetic Stimulation

Sham and the active rTMS

SHAM COMPARATOR

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.

Device: repetitive Transcranial Magnetic Stimulation

Interventions

repetitive Transcranial Magnetic Stimulation DEVICE

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.

Active and then sham rTMS; Sham and the active rTMS

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Ability to follow throughout the whole duration of the study

You may not qualify if:

• 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
• Pain conditions more severe than peripheral neuropathic pain
• Inability to understand the protocol or to fill out the forms

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Department of Pain Management and Research, Oslo University Hospital and Faculty of Medicine, University of Oslo,

Oslo, 0424, Norway

Location

Related Publications (3)

• 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.

  PMID: 27115670 BACKGROUND

• Farnes N, Stubhaug A, Hansson P, Vambheim SM. H-Coil Repetitive Transcranial Magnetic Stimulation Relieves Pain and Symptoms of Anxiety and Depression in Patients With Chronic Peripheral Neuropathic Pain: A Randomized Sham-Controlled Crossover Study. Neuromodulation. 2024 Dec;27(8):1372-1382. doi: 10.1016/j.neurom.2024.09.002. Epub 2024 Nov 2.

  PMID: 39488777 DERIVED

• Farnes N, Jacobsen HB, Stubhaug A, Vambheim SM. H-coil repetitive transcranial magnetic stimulation does not improve executive function in patients with chronic peripheral neuropathic pain: a randomized sham-controlled crossover study. Front Psychiatry. 2024 Jul 17;15:1401008. doi: 10.3389/fpsyt.2024.1401008. eCollection 2024.

  PMID: 39086728 DERIVED

MeSH Terms

Conditions

Neuralgia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Audun Stubhaug, MD, PhD

  OUS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. student

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 5, 2022
• Study Start: February 1, 2022
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)