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
5 participants
INTERVENTIONAL
2022-04-22
2023-09-22
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
DOUBLE
Study Groups
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PAS
long-term paired associative stimulation
Paired associative stimulation (PAS) administered 3-5 times per week for 4 weeks to upper limbs. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).
SHAM
sham long-term paired associative stimulation
Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.
Interventions
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long-term paired associative stimulation
Paired associative stimulation (PAS) administered 3-5 times per week for 4 weeks to upper limbs. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).
sham long-term paired associative stimulation
Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.
Eligibility Criteria
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Inclusion Criteria
* time from injury at least 1.5 years
* chronic SCI- induced neuropathic pain in the upper limb
Exclusion Criteria
* No activity in hands/fingers and no MEPs recorded from distal hand muscles.
* Epilepsy
* Metal inclusion in the head area
* High intracranial pressure
* Pacemaker
* Implanted hearing device
* Progressive diseases of spinal cord or brain (e.g. malignant tumors, degenerative diseases).
* Previous head or spinal cord injury affecting the motor performance of upper extremities.
* Congenital anomaly in the anatomical structure of spinal canal/cord or dura.
* Significant systemic disease or other condition that could cause neurological deficit, or may affect subject's capability to undergo investigation-related procedures.
* Acute severe infection.
* Contraindications for MRI.
* Current severe psychiatric diseases.
* Current chronic drug and/or alcohol abuse.
* Pregnancy.
* Pressure ulcer affecting the subject's capability to undergo the procedure safely
18 Years
75 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Anastasia Shulga
Head of Department
Locations
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Helsinki University Hospital
Helsinki, , Finland
Countries
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References
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Shulga A, Lioumis P, Kirveskari E, Savolainen S, Makela JP. A novel paired associative stimulation protocol with a high-frequency peripheral component: A review on results in spinal cord injury rehabilitation. Eur J Neurosci. 2021 May;53(9):3242-3257. doi: 10.1111/ejn.15191. Epub 2021 Mar 29.
Vaalto S, Nyman AL, Shulga A. Analgesic effect of paired associative stimulation in a tetraplegic patient with severe drug-resistant neuropathic pain: a case report. Scand J Pain. 2021 May 21;21(4):831-838. doi: 10.1515/sjpain-2021-0012. Print 2021 Oct 26.
Other Identifiers
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TYH2020244
Identifier Type: -
Identifier Source: org_study_id
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