PAS in Subacute SCI
Primary Purpose
Spinal Cord Injuries, Spinal Cord Diseases
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Paired associative stimulation
Sham paired associative stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility Criteria
Inclusion Criteria:
- SCI caused by an external trauma or SCI caused by nontraumatic non-progressive disease of the spinal cord
- Cervical level injury, tetraplegia
- Time from injury/onset of symptoms 1-4 months
- Medical condition stable
- Residual neural connectivity in upper extremity: some voluntary activity in finger muscles or MEPs obtainable from distal hand muscles
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).
- History of malignant tumor within the past 5 years.
- 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.
- Severe emergency care polyneuropathy
- Pressure ulcer affecting the subject's capability to undergo the procedure safely
Sites / Locations
- BioMag laboratory, Helsinki University Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Paired Associative Stimulation
Sham
Arm Description
Outcomes
Primary Outcome Measures
Daniels and Worthingham's Muscle Testing
hand muscle strength is evaluated on 0-5 scale (0=no movement, 5=normal)
Spinal Cord Independence Measure (SCIM)
standard SCIM evaluation
Secondary Outcome Measures
Full Information
NCT ID
NCT04101916
First Posted
September 18, 2019
Last Updated
February 27, 2023
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04101916
Brief Title
PAS in Subacute SCI
Official Title
Paired Associative Stimulation in Subacute Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Spinal Cord Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paired Associative Stimulation
Arm Type
Experimental
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Paired associative stimulation
Intervention Description
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)).
Intervention Type
Device
Intervention Name(s)
Sham paired associative stimulation
Intervention Description
Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.
Primary Outcome Measure Information:
Title
Daniels and Worthingham's Muscle Testing
Description
hand muscle strength is evaluated on 0-5 scale (0=no movement, 5=normal)
Time Frame
Change from baseline score immediately after, 6 months after and 1 year after last stimulation session
Title
Spinal Cord Independence Measure (SCIM)
Description
standard SCIM evaluation
Time Frame
Change from baseline score immediately after, 6 months after and 1 year after last stimulation session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
SCI caused by an external trauma or SCI caused by nontraumatic non-progressive disease of the spinal cord
Cervical level injury, tetraplegia
Time from injury/onset of symptoms 1-4 months
Medical condition stable
Residual neural connectivity in upper extremity: some voluntary activity in finger muscles or MEPs obtainable from distal hand muscles
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).
History of malignant tumor within the past 5 years.
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.
Severe emergency care polyneuropathy
Pressure ulcer affecting the subject's capability to undergo the procedure safely
Facility Information:
Facility Name
BioMag laboratory, Helsinki University Central Hospital
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00029
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
28635523
Citation
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.
Results Reference
background
PubMed Identifier
28053760
Citation
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.
Results Reference
background
PubMed Identifier
30846765
Citation
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.
Results Reference
background
PubMed Identifier
25597909
Citation
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.
Results Reference
background
PubMed Identifier
27721747
Citation
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.
Results Reference
background
PubMed Identifier
31886442
Citation
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.
Results Reference
background
PubMed Identifier
31632739
Citation
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.
Results Reference
background
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PAS in Subacute SCI
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