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Treatment of Peripheral Neuropathic Pain (BrainStim)

Primary Purpose

Neuropathic Pain

Status

Recruiting

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

repetitive Transcranial Magnetic Stimulation

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 18 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active and then sham rTMS

Sham and the active rTMS

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Usual pain intensity over the past 24 hours

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)

Pain intensity over the last 24 hours

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

Pain unpleasantness during the last 24 hours

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

Intensity of dynamic mechanical allodynia

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.

Intensity of static mechanical allodynia

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.

Proportion of responders

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.

Percentage pain intensity reduction

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

Hospital Anxiety and Depression Scale

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

Pain Catastrophizing Scale

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)

Patient Global Impression of Change

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

Insomnia Severity Index

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

Patient-Specific Functional Scale

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)

Executive functioning using the CANTAB battery

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

Side-effects

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

Blinding

Blinding questionnaire

Full Information

NCT ID

NCT05488808

First Posted

August 3, 2022

Last Updated

August 4, 2022

Sponsor

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05488808

Brief Title

Treatment of Peripheral Neuropathic Pain

Acronym

BrainStim

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2022 (Actual)

Primary Completion Date

February 1, 2027 (Anticipated)

Study Completion Date

February 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain

Keywords

Repetitive Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active and then sham rTMS

Arm Type

Active Comparator

Arm 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.

Arm Title

Sham and the active rTMS

Arm Type

Sham Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

repetitive Transcranial Magnetic Stimulation

Intervention 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.

Primary Outcome Measure Information:

Title

Usual pain intensity over the past 24 hours

Description

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)

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]

Secondary Outcome Measure Information:

Title

Usual pain intensity over the past 24 hours

Description

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)

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

Title

Pain intensity over the last 24 hours

Description

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

Time Frame

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

Title

Pain unpleasantness during the last 24 hours

Description

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

Time Frame

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

Title

Intensity of dynamic mechanical allodynia

Description

Time Frame

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

Title

Intensity of static mechanical allodynia

Description

Time Frame

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

Title

Proportion of responders

Description

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.

Time Frame

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

Title

Percentage pain intensity reduction

Description

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

Time Frame