NCT03104803

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

1.2 years

First QC Date

April 1, 2017

Last Update Submit

September 23, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Daniels and Worthingham's Muscle Testing

    each hand muscle is evaluated on 0-5 scale

    2 days after the last stimulation session

  • Daniels and Worthingham's Muscle Testing

    each hand muscle is evaluated on 0-5 scale

    1 month after the last stimulation session

Study Arms (2)

Long-term PAS

EXPERIMENTAL

The intervention is given to one hand only

Device: long-term paired associative stimulation

No intervention

NO INTERVENTION

Contralateral hand of the same patient

Interventions

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)).

Long-term PAS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • incomplete SCI of non-traumatic origin

You may not qualify if:

  • epilepsy
  • pacemaker
  • hearing device
  • high intracranial pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioMag laboratory

Helsinki, Finland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Spinal Cord DiseasesSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 1, 2017

First Posted

April 7, 2017

Study Start

March 31, 2017

Primary Completion

May 27, 2018

Study Completion

October 30, 2018

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations