NCT03045744

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.

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 Feb 2017

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

February 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

February 10, 2017

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

6.3 years

First QC Date

February 2, 2017

Last Update Submit

May 12, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Daniels and Worthingham's Muscle Testing

    2 days after the last stimulation session

  • Daniels and Worthingham's Muscle Testing

    1 month after the last stimulation session

Study Arms (1)

incomplete SCI patients

EXPERIMENTAL
Device: long-term paired associative stimulation

Interventions

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)).

incomplete SCI patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • incomplete SCI

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 University Central Hospital

Helsinki, Uusimaa, 00029, Finland

Location

Related Publications (2)

  • 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.

  • Holopainen K, Tolmacheva A, Bersch I, Haakana P, Pohjonen M, Kirveskari E, Arokoski J, Shulga A. Stable improvement in hand muscle strength in incomplete spinal cord injury patients by long-term paired associative stimulation-a case series study. Front Neurol. 2025 Feb 4;16:1486591. doi: 10.3389/fneur.2025.1486591. eCollection 2025.

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Anastasia Shulga, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 7, 2017

Study Start

February 10, 2017

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

May 13, 2025

Record last verified: 2025-05

Locations