Neuropathic PainBrainStimNCT05488808
Treatment of Peripheral Neuropathic Pain
A study testing repetitive Transcranial Magnetic Stimulation in people with Neuropathic Pain, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2022to 24 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Pain Management and Research, Oslo University Hospital and Faculty of Medicine, University of Oslo,
Oslo, 0424
About this study
Official title: Deep Repetitive Transcranial Magnetic Stimulation for Peripheral Neuropathic Pain. A Randomized Double-blind Sham-controlled Study.
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
- Being tested
- repetitive Transcranial Magnetic Stimulation
- Keywords
- Repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: 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
Maximum and minimum pain intensity hours, rated from 0 (no pain) to 10 (pain as bad as you can imagine)
Measured: Baseline, 1 week and 3 weeks after the end of each stimulation period
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)
Measured: Baseline, 1 week and 3 weeks after the end of each stimulation period
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.
Measured: Baseline, 1 week and 3 weeks after the end of each stimulation period
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.
Measured: Baseline, 1 week and 3 weeks after the end of each stimulation period
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.
Measured: Baseline,1 week and 3 weeks after the end of each stimulation period]
Percentage pain intensity reduction
Percentage pain intensity reduction on an 11-point NRS (0 %= no pain reduction; 100% complete pain reduction)
Measured: Baseline,1 week and 3 weeks after the end of each stimulation period
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
Measured: Baseline,1 week and 3 weeks after the end of each stimulation period
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)
Measured: Baseline,1 week and 3 weeks after the end of each stimulation period
Patient Global Impression of Change
Consists of 7 items to evaluate the subjective improvement or deterioration (from very much improved to very much deteriorated)
Measured: Baseline,1 week and 3 weeks after the end of each stimulation period
Insomnia Severity Index
Consists of self-rated questions which maps sleep difficulties specific to insomnia on a 5 point Likert scale
Measured: Baseline,1 week and 3 weeks after the end of each stimulation period
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)
Measured: Baseline,1 week and 3 weeks after the end of each stimulation period
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
Measured: Baseline,1 week and 3 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
Measured: Immediately after the first rTMS session for both stimulation periods and 1 week and 3 weeks after each stimulation period
Blinding
Blinding questionnaire
Measured: 3 weeks after the end of each stimulation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Feb 2022
- Primary completion24 Nov 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine Farnes, Oslo University Hospital
- Investigators
- Audun Stubhaug, MD, PhD, Study director, OUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488808
- Sponsor's protocol ID
- 428116
- Acronym
- BrainStim
- Status last verified
- Nov 2023
- First submitted
- 3 Aug 2022
- Last updated
- 27 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified individual participant data collected during the trial will be available to other researchers who provide a methodologically sound proposal, and who adhere to institutional guidelines.
Publications
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.
PubMed 27115670Farnes 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.
PubMed 39488777Farnes 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.
PubMed 39086728
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Repetitive Transcranial Magnetic Stimulation for Peripheral Neuropathic Pain. A Randomized Double-blind Sham-controlled Study.
- ClinicalTrials.gov ID
- NCT05488808
- Acronym / sponsor ID
- BrainStim / 428116
- Conditions
- Neuropathic Pain
- Keywords
- Repetitive Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active and then sham rTMS | Active comparator | Device: repetitive Transcranial Magnetic StimulationDeep 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 and the active rTMS | Sham comparator | Device: repetitive Transcranial Magnetic StimulationSham 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. |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive Transcranial Magnetic StimulationDeep 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. | Device | Active and then sham rTMS, Sham and the active rTMS |
Primary outcome
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)
15 secondary outcomes
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
Pain intensity over the last 24 hours
Time frame: Baseline, 1 week and 3 weeks after the end of each stimulation period
Pain unpleasantness during the last 24 hours
Time frame: Baseline, 1 week and 3 weeks after the end of each stimulation period
Intensity of dynamic mechanical allodynia
Time frame: Baseline, 1 week and 3 weeks after the end of each stimulation period
Intensity of static mechanical allodynia
Time frame: Baseline, 1 week and 3 weeks after the end of each stimulation period
Proportion of responders
Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period]
Percentage pain intensity reduction
Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period
Hospital Anxiety and Depression Scale
Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period
Pain Catastrophizing Scale
Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period
Patient Global Impression of Change
Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period
Insomnia Severity Index
Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period
Patient-Specific Functional Scale
Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period
Executive functioning using the CANTAB battery
Time frame: Baseline,1 week and 3 weeks after the end of each stimulation period
Side-effects
Time frame: Immediately after the first rTMS session for both stimulation periods and 1 week and 3 weeks after each stimulation period
Blinding
Time frame: 3 weeks after the end of each stimulation period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Background: PubMed 27115670Finnerup 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.
- Derived from this study: PubMed 39488777Farnes 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.
- Derived from this study: PubMed 39086728Farnes 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.
- Individual participant dataSharing planned: No. Deidentified individual participant data collected during the trial will be available to other researchers who provide a methodologically sound proposal, and who adhere to institutional guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audun Stubhaug, MD, PhD study director
OUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive Transcranial Magnetic Stimulation in people with Neuropathic Pain, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05488808, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.