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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104803
• Other study ID #: ULD 8100014-2
• Status: Completed
• Phase: N/A
• Start date: March 31, 2017
• Est. completion date: October 30, 2018

Study information

• Verified date: September 2019
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 30, 2018
• Est. primary completion date: May 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• incomplete SCI of non-traumatic origin

Exclusion Criteria:

• epilepsy

• metal inclusion in the head area

• pacemaker

• hearing device

• high intracranial pressure

Related Conditions & MeSH terms

• Spinal Cord Diseases
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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)).

Locations

Country	Name	City	State
Finland	BioMag laboratory	Helsinki

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Helsinki University, Validia Rehabilitation Center

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Tolmacheva A, Savolainen S, Kirveskari E, Branstack N, Mäkelä JP, Shulga A. Paired associative stimulation improves hand function after non-traumatic spinal cord injury: A case series. Clinical Neurophysiology Practice, 4: 178-183, 2019.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daniels and Worthingham's Muscle Testing	each hand muscle is evaluated on 0-5 scale	2 days after the last stimulation session
Primary	Daniels and Worthingham's Muscle Testing	each hand muscle is evaluated on 0-5 scale	1 month after the last stimulation session