CClinicalTrials.gg
Sign In
CompletedNCT03459885Updated May 13, 2025

PAS for Lower Extremity Rehabilitation in Tetraplegic Patients

An interventional study of Paired associative stimulation (with eXimia magnetic stimulator and Dantec Keypoint® electroneuromyography device) in Spinal Cord Injuries and Spinal Cord Diseases, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-13.

Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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 (1,2). In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete cervical level SCI and investigate its effectiveness for lower extremity rehabilitation.

02

Conditions studied

  • Spinal Cord Injuries
  • Spinal Cord Diseases
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • cervical incomplete SCI

Exclusion criteria

Exclusion Criteria:

  • epilepsy
  • metal inclusion in the head area
  • pacemaker
  • hearing device
  • high intracranial pressure
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    PAS

    The intervention is given to peripheral nerve - motor cortex pairs selected by the investigator.

    Device: Paired associative stimulation (with eXimia magnetic stimulator and Dantec Keypoint® electroneuromyography device)

Interventions

  • DevicePaired associative stimulation (with eXimia magnetic stimulator and Dantec Keypoint® electroneuromyography device)

    Paired associative stimulation (PAS) administered several times per week for 8 weeks to lower limbs. 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)).

05

What researchers measure

Primary outcomes

  1. Daniels and Worthingham's Muscle Testing

    Leg muscle stenght is evaluated on 0-5 scale (0=no movement, 5=normal)

    Time frame: 2 days after the last stimulation session

  2. Daniels and Worthingham's Muscle Testing

    leg muscles are evaluated on 0-5 scale

    Time frame: 1 month after the last stimulation session

06

Study locations

1 site
  • BioMag laboratory, Helsinki University Central Hospital
    Helsinki, Uusimaa 00029, Finland
07

References and documents

Publications

  • Shulga A, Lioumis P, Zubareva A, Brandstack N, Kuusela L, Kirveskari E, Savolainen S, Ylinen A, Makela JP. Long-term paired associative stimulation can restore voluntary control over paralyzed muscles in incomplete chronic spinal cord injury patients. Spinal Cord Ser Cases. 2016 Jul 14;2:16016. doi: 10.1038/scsandc.2016.16. eCollection 2016. PubMed 28053760 ↗
  • Tolmacheva A, Savolainen S, Kirveskari E, Lioumis P, Kuusela L, Brandstack N, Ylinen A, Makela JP, Shulga A. Long-Term Paired Associative Stimulation Enhances Motor Output of the Tetraplegic Hand. J Neurotrauma. 2017 Sep 15;34(18):2668-2674. doi: 10.1089/neu.2017.4996. Epub 2017 Jul 21. PubMed 28635523 ↗
  • Rodionov A, Savolainen S, Kirveskari E, Makela JP, Shulga A. Effects of Long-Term Paired Associative Stimulation on Strength of Leg Muscles and Walking in Chronic Tetraplegia: A Proof-of-Concept Pilot Study. Front Neurol. 2020 May 20;11:397. doi: 10.3389/fneur.2020.00397. eCollection 2020. PubMed 32508738 ↗
08

Registry details

Key details

Study ID
NCT03459885
Lead sponsor
Helsinki University Central Hospital
Collaborators
Validia Rehabilitation Centre
Responsible party
Anastasia Shulga (Principal Investigator, Helsinki University Central Hospital) — Principal investigator
First posted
Mar 9, 2018
Start date
Feb 28, 2018
Primary completion
Jun 28, 2019
Completion
Jun 28, 2019
Last update
May 13, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Spinal Cord Injuries→

Other studies from this sponsor

Helsinki University Central Hospital

Start the discussion