PAS in Subacute SCI
Study Details
Study Description
Brief Summary
The investigators have recently 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 at the subacute stage, and investigate its effectiveness for upper extremity rehabilitation.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Paired Associative Stimulation
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Device: Paired associative stimulation
Paired associative stimulation (PAS) administered several times per week for 12 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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Sham Comparator: Sham
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Device: Sham paired associative stimulation
Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.
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Outcome Measures
Primary Outcome Measures
- Daniels and Worthingham's Muscle Testing [Change from baseline score immediately after, 6 months after and 1 year after last stimulation session]
hand muscle strength is evaluated on 0-5 scale (0=no movement, 5=normal)
- Spinal Cord Independence Measure (SCIM) [Change from baseline score immediately after, 6 months after and 1 year after last stimulation session]
standard SCIM evaluation
Eligibility Criteria
Criteria
Inclusion Criteria:
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SCI caused by an external trauma or SCI caused by nontraumatic non-progressive disease of the spinal cord
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Cervical level injury, tetraplegia
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Time from injury/onset of symptoms 1-4 months
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Medical condition stable
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Residual neural connectivity in upper extremity: some voluntary activity in finger muscles or MEPs obtainable from distal hand muscles
Exclusion Criteria:
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Diagnosed brain damage, visible in MRI or CT.
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No activity in hands/fingers and no MEPs recorded from distal hand muscles.
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Epilepsy
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Metal inclusion in the head area
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High intracranial pressure
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Pacemaker
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Implanted hearing device
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Progressive diseases of spinal cord or brain (e.g. malignant tumors, degenerative diseases).
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History of malignant tumor within the past 5 years.
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Previous head or spinal cord injury affecting the motor performance of upper extremities.
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Congenital anomaly in the anatomical structure of spinal canal/cord or dura.
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Significant systemic disease or other condition that could cause neurological deficit, or may affect subject's capability to undergo investigation-related procedures.
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Acute severe infection.
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Contraindications for MRI.
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Current severe psychiatric diseases.
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Current chronic drug and/or alcohol abuse.
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Pregnancy.
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Severe emergency care polyneuropathy
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Pressure ulcer affecting the subject's capability to undergo the procedure safely
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | BioMag laboratory, Helsinki University Central Hospital | Helsinki | Uusimaa | Finland | 00029 |
Sponsors and Collaborators
- Helsinki University Central Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Rodionov A, Savolainen S, Kirveskari E, Mäkelä JP, Shulga A. Restoration of hand function with long-term paired associative stimulation after chronic incomplete tetraplegia: a case study. Spinal Cord Ser Cases. 2019 Oct 1;5:81. doi: 10.1038/s41394-019-0225-5. eCollection 2019.
- Shulga A, Lioumis P, Kirveskari E, Savolainen S, Mäkelä JP, Ylinen A. The use of F-response in defining interstimulus intervals appropriate for LTP-like plasticity induction in lower limb spinal paired associative stimulation. J Neurosci Methods. 2015 Mar 15;242:112-7. doi: 10.1016/j.jneumeth.2015.01.012. Epub 2015 Jan 15.
- Shulga A, Lioumis P, Zubareva A, Brandstack N, Kuusela L, Kirveskari E, Savolainen S, Ylinen A, Mäkelä JP. Long-term paired associative stimulation can restore voluntary control over paralyzed muscles in incomplete chronic spinal cord injury patients. Spinal Cord Ser Cases. 2016 Jul 14;2:16016. doi: 10.1038/scsandc.2016.16. eCollection 2016.
- Shulga A, Zubareva A, Lioumis P, Mäkelä JP. Paired Associative Stimulation with High-Frequency Peripheral Component Leads to Enhancement of Corticospinal Transmission at Wide Range of Interstimulus Intervals. Front Hum Neurosci. 2016 Sep 23;10:470. eCollection 2016.
- Tolmacheva A, Mäkelä JP, Shulga A. Increasing the frequency of peripheral component in paired associative stimulation strengthens its efficacy. Sci Rep. 2019 Mar 7;9(1):3849. doi: 10.1038/s41598-019-40474-0.
- Tolmacheva A, Savolainen S, Kirveskari E, Brandstack N, Mäkelä JP, Shulga A. Paired associative stimulation improves hand function after non-traumatic spinal cord injury: A case series. Clin Neurophysiol Pract. 2019 Aug 13;4:178-183. doi: 10.1016/j.cnp.2019.07.002. eCollection 2019.
- Tolmacheva A, Savolainen S, Kirveskari E, Lioumis P, Kuusela L, Brandstack N, Ylinen A, Mäkelä JP, Shulga A. Long-Term Paired Associative Stimulation Enhances Motor Output of the Tetraplegic Hand. J Neurotrauma. 2017 Sep 15;34(18):2668-2674. doi: 10.1089/neu.2017.4996. Epub 2017 Jul 21.
- WFL-FI-15/19