Treatment of Peripheral Neuropathic Pain

Neuropathic Pain Clinical Trial

— BrainStim  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05488808
• Other study ID #: 428116
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: November 24, 2023

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 24, 2023
• Est. primary completion date: November 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Device:
• repetitive Transcranial Magnetic Stimulation
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.

Locations

Country	Name	City	State
Norway	Department of Pain Management and Research, Oslo University Hospital and Faculty of Medicine, University of Oslo,	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	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
Secondary	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)	Baseline, 1 week and 3 weeks after the end of each stimulation period
Secondary	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)	Baseline, 1 week and 3 weeks after the end of each stimulation period
Secondary	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.	Baseline, 1 week and 3 weeks after the end of each stimulation period
Secondary	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.	Baseline, 1 week and 3 weeks after the end of each stimulation period
Secondary	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.	Baseline,1 week and 3 weeks after the end of each stimulation period]
Secondary	Percentage pain intensity reduction	Percentage pain intensity reduction on an 11-point NRS (0 %= no pain reduction; 100% complete pain reduction)	Baseline,1 week and 3 weeks after the end of each stimulation period
Secondary	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	Baseline,1 week and 3 weeks after the end of each stimulation period
Secondary	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)	Baseline,1 week and 3 weeks after the end of each stimulation period
Secondary	Patient Global Impression of Change	Consists of 7 items to evaluate the subjective improvement or deterioration (from very much improved to very much deteriorated)	Baseline,1 week and 3 weeks after the end of each stimulation period
Secondary	Insomnia Severity Index	Consists of self-rated questions which maps sleep difficulties specific to insomnia on a 5 point Likert scale	Baseline,1 week and 3 weeks after the end of each stimulation period
Secondary	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)	Baseline,1 week and 3 weeks after the end of each stimulation period
Secondary	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	Baseline,1 week and 3 weeks after the end of each stimulation period
Secondary	Side-effects	Side effects using a specific side effects questionnaire specifically designed for assessment of safety in rTMS studies	Immediately after the first rTMS session for both stimulation periods and 1 week and 3 weeks after each stimulation period
Secondary	Blinding	Blinding questionnaire	3 weeks after the end of each stimulation period