Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paired Associative Stimulation | Experimental |
| |
| Sham | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paired associative stimulation | Device | 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)). |
| Measure | Description | Time Frame |
|---|---|---|
| Daniels and Worthingham's Muscle Testing | hand muscle strength is evaluated on 0-5 scale (0=no movement, 5=normal) | Change from baseline score immediately after, 6 months after and 1 year after last stimulation session |
| Spinal Cord Independence Measure (SCIM) | standard SCIM evaluation | Change from baseline score immediately after, 6 months after and 1 year after last stimulation session |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioMag laboratory, Helsinki University Central Hospital | Helsinki | Uusimaa | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28635523 | Background | Tolmacheva A, Savolainen S, Kirveskari E, Lioumis P, Kuusela L, Brandstack N, Ylinen A, Makela 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. | |
| 28053760 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D013118 | Spinal Cord Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
Not provided
Not provided
The aim is 20 participants and the anticipated dropout percentage is 20%, therefore maximum number of randomized patients will be 24. If there will be no dropouts, only 20 patients will be recruited.
Not provided
Not provided
Not provided
|
| Sham paired associative stimulation | Device | Sham transcranial magnetic stimulation and sham peripheral nerve stimulation. |
|
| Shulga A, Lioumis P, Zubareva A, Brandstack N, Kuusela L, Kirveskari E, Savolainen S, Ylinen A, Makela 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. |
| 30846765 | Background | Tolmacheva A, Makela 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. |
| 25597909 | Background | Shulga A, Lioumis P, Kirveskari E, Savolainen S, Makela 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. |
| 27721747 | Background | Shulga A, Zubareva A, Lioumis P, Makela 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. doi: 10.3389/fnhum.2016.00470. eCollection 2016. |
| 31886442 | Background | Tolmacheva A, Savolainen S, Kirveskari E, Brandstack N, Makela 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. |
| 31632739 | Background | Rodionov A, Savolainen S, Kirveskari E, Makela 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. |