Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2022-02-01
2023-11-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Active and then sham rTMS
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.
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.
Sham and the active rTMS
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
18 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Nadine Farnes
Ph.D. student
Principal Investigators
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Audun Stubhaug, MD, PhD
Role: STUDY_DIRECTOR
OUS
Locations
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Department of Pain Management and Research, Oslo University Hospital and Faculty of Medicine, University of Oslo,
Oslo, , Norway
Countries
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References
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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.
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.
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.
Other Identifiers
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428116
Identifier Type: -
Identifier Source: org_study_id