Long-term PAS in Rehabilitation After SCI

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03045744
• Collaborator: Validia Rehabilitation (Other), University of Helsinki (Other)
• Enrollment: 5
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 69.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The investigators have recently shown in two pilot 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 incomplete SCI patients in a long-term manner, keeping each patient in the study for as long as continuous improvement is observed.

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Long-term Paired Associative Stimulation in Rehabilitation of Spinal Cord Injury Patients
• Actual Study Start Date: Feb 1, 2017
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: incomplete SCI patients	Device: long-term paired associative stimulation; Paired associative stimulation (PAS) administered 3 times per week. 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)).

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• incomplete SCI

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 University Central Hospital	Helsinki	Uusimaa	Finland	00029

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Anastasia Shulga, MD, PhD, Helsinki University Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anastasia Shulga, Principle Investigator, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT03045744
• Other Study ID Numbers: ULD 8100014
• First Posted: Feb 7, 2017
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Spinal Cord Injuries

Study Results

No Results Posted as of Mar 16, 2022