PAS in Subacute SCI

NCT04101916 | Completed

• 1 other identifier: WFL-FI-15/19
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Paired Associative Stimulation

EXPERIMENTAL

Device: Paired associative stimulation

Sham

SHAM COMPARATOR

Device: Sham paired associative stimulation

Interventions

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)).

Paired Associative Stimulation

Sham paired associative stimulation DEVICE

Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.

Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosed brain damage, visible in MRI or CT.
• No activity in hands/fingers and no MEPs recorded from distal hand muscles.
• Epilepsy
• 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.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

BioMag laboratory, Helsinki University Central Hospital

Helsinki, Uusimaa, 00029, Finland

Location

Related Publications (7)

• 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.

  PMID: 28635523 BACKGROUND

• 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.

  PMID: 28053760 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.

  PMID: 30846765 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.

  PMID: 25597909 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.

  PMID: 27721747 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.

  PMID: 31886442 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.

  PMID: 31632739 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 24, 2019
• Study Start: October 10, 2019
• Primary Completion: January 13, 2025
• Study Completion: January 13, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

FI (1)