- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05362422
PAS for Post-SCI Neuropathic Pain
September 22, 2023 updated by: Anastasia Shulga, Helsinki University Central Hospital
Paired Associative Stimulation for Post- Spinal Cord Injury Neuropathic Pain
The investigators have shown in incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles.
In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete cervical level SCI and SCI- associated neuropathic pain, and investigate its effectiveness for neuropathic pain treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Helsinki, Finland
- Helsinki University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- incomplete cervical spinal cord injury
- time from injury at least 1.5 years
- chronic SCI- induced neuropathic pain in the upper limb
Exclusion Criteria:
- Diagnosed brain damage, visible in MRI or CT.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Sham Comparator: SHAM
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Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.
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Experimental: PAS
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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)).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Pain Inventory
Time Frame: Change from baseline at 1 day after the intervention
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0-10 scale, 0 - no pain, 10 - worst possible pain.
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Change from baseline at 1 day after the intervention
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Brief Pain Inventory
Time Frame: Change from baseline at 8 weeks after the intervention
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0-10 scale, 0 - no pain, 10 - worst possible pain.
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Change from baseline at 8 weeks after the intervention
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Numeric Rating Scale
Time Frame: Change from baseline at 1 day after the intervention
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0-10 scale, 0 - no pain, 10 - worst possible pain.
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Change from baseline at 1 day after the intervention
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Numeric Rating Scale
Time Frame: Change from baseline at 8 weeks after the intervention
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0-10 scale, 0 - no pain, 10 - worst possible pain.
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Change from baseline at 8 weeks after the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 22, 2022
Primary Completion (Actual)
May 22, 2023
Study Completion (Actual)
September 22, 2023
Study Registration Dates
First Submitted
April 22, 2022
First Submitted That Met QC Criteria
May 2, 2022
First Posted (Actual)
May 5, 2022
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 22, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TYH2020244
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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