Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03104803
• Collaborator: Validia Rehabilitation Center (Other), University of Helsinki (Other)
• Enrollment: 5
• Location: 1
• Arms: 2
• Actual Duration (Months): 19
• Patients Per Site Per Month: 0.3

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 (1). In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete SCI of non-traumatic origin.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Diseases; Spinal Cord Injuries	Device: long-term paired associative stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin
• Actual Study Start Date: Mar 31, 2017
• Actual Primary Completion Date: May 27, 2018
• Actual Study Completion Date: Oct 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Long-term PAS The intervention is given to one hand only	Device: long-term paired associative stimulation; Paired associative stimulation (PAS) administered several times per week for 6 weeks to one hand. 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)).
No Intervention: No intervention Contralateral hand of the same patient

Outcome Measures

Primary Outcome Measures

1. Daniels and Worthingham's Muscle Testing [2 days after the last stimulation session]

   each hand muscle is evaluated on 0-5 scale

2. Daniels and Worthingham's Muscle Testing [1 month after the last stimulation session]

   each hand muscle is evaluated on 0-5 scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• incomplete SCI of non-traumatic origin

Exclusion Criteria:

• epilepsy

• metal inclusion in the head area

• pacemaker

• hearing device

• high intracranial pressure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BioMag laboratory	Helsinki		Finland

Sponsors and Collaborators

• Helsinki University Central Hospital
• Validia Rehabilitation Center
• University of Helsinki

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anastasia Shulga, MD, PhD, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT03104803
• Other Study ID Numbers: ULD 8100014-2
• First Posted: Apr 7, 2017
• Last Update Posted: Sep 25, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Spinal Cord Injuries; Spinal Cord Diseases; Wounds and Injuries

Study Results

No Results Posted as of Sep 25, 2019