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Completed

NCT Number: NCT05488808

Treatment of Peripheral Neuropathic Pain

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.

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Key information

Conditions

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

Age range

18 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Oslo, 0424, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. 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 and 3 weeks after the last stimulation

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

  2. Pain intensity over the last 24 hours

    Time frame: Baseline, 1 week and 3 weeks after the end of each stimulation period

    Maximum and minimum pain intensity hours, rated from 0 (no pain) to 10 (pain as bad as you can imagine)

  3. Pain unpleasantness during the last 24 hours

    Time frame: Baseline, 1 week and 3 weeks after the end of each stimulation period

    Maximum, minimum, and usual pain unpleasantness, rated from 0 (no pain/unpleasantness) to 10 (unpleasantness as bad as you can imagine)

  4. Intensity of dynamic mechanical allodynia

    Time frame: Baseline, 1 week and 3 weeks after the end of each stimulation period

    Dynamic mechanical allodynia is assessed using a brush (SOMEDIC). The outcome is the mean pain intensity of 3 brush strokes within 2 seconds intervals. The length of the brush stroke is 3 cm, measured on an 11-point NRS (0 = no pain, 10 = worst pain intensity imaginable), disregarding the spontaneous ongoing pain.

  5. Intensity of static mechanical allodynia

    Time frame: Baseline, 1 week and 3 weeks after the end of each stimulation period

    Static mechanical allodynia is measured with a stimulus lightly indenting the skin for 10 seconds. The outcome is the mean pain intensity of three presses, measured on an 11-point NRS (0 = no pain, 10 = worst pain intensity imaginable), disregarding the spontaneous ongoing pain.

  6. Proportion of responders

    Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period]

    Proportion of responders with at least 30% and 50% usual pain intensity reduction compared to prestimulation values allowing to calculate Numbers Needed to Treat for 30 % and 50 % pain relief.

  7. Percentage pain intensity reduction

    Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period

    Percentage pain intensity reduction on an 11-point NRS (0 %= no pain reduction; 100% complete pain reduction)

  8. Hospital Anxiety and Depression Scale

    Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period

    The Hospital Anxiety and Depression Scale includes 14 items scored as anxiety and depression scores, 7 items assessing depression and 7 anxiety

  9. Pain Catastrophizing Scale

    Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period

    Consists of 13 items describing the occurrence of thoughts and feelings that individuals may experience when in pain rated from 0 (not at all) to 4 (all the time)

  10. Patient Global Impression of Change

    Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period

    Consists of 7 items to evaluate the subjective improvement or deterioration (from very much improved to very much deteriorated)

  11. Insomnia Severity Index

    Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period

    Consists of self-rated questions which maps sleep difficulties specific to insomnia on a 5 point Likert scale

  12. Patient-Specific Functional Scale

    Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period

    The Patient-Specific Functional Scale is a numeric rating scale that measures individually chosen functions that are inhibited by the pain. Patients rate from 0 (unable to perform activity) to 10 (able to perform activity)

  13. Executive functioning using the CANTAB battery

    Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period

    Composite score and individual analyses of the paired associates learning test, stop signal task, spatial working memory test and the multitasking test weeks after the end of each stimulation period

  14. Side-effects

    Time frame: Immediately after the first rTMS session for both stimulation periods and 1 week and 3 weeks after each stimulation period

    Side effects using a specific side effects questionnaire specifically designed for assessment of safety in rTMS studies

  15. Blinding

    Time frame: 3 weeks after the end of each stimulation period

    Blinding questionnaire

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Acronym: BrainStim

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 5, 2022
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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