NCT05362422

Brief Summary

The investigators have 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. In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete cervical level SCI and SCI- associated neuropathic pain, and investigate its effectiveness for neuropathic pain treatment.

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 Apr 2022

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

April 22, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 22, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

April 22, 2022

Last Update Submit

September 22, 2023

Conditions

Spinal Cord Injury CervicalNeuropathic Pain

Outcome Measures

Primary Outcomes (4)

  • Brief Pain Inventory

    0-10 scale, 0 - no pain, 10 - worst possible pain.

    Change from baseline at 1 day after the intervention

  • Brief Pain Inventory

    0-10 scale, 0 - no pain, 10 - worst possible pain.

    Change from baseline at 8 weeks after the intervention

  • Numeric Rating Scale

    0-10 scale, 0 - no pain, 10 - worst possible pain.

    Change from baseline at 1 day after the intervention

  • Numeric Rating Scale

    0-10 scale, 0 - no pain, 10 - worst possible pain.

    Change from baseline at 8 weeks after the intervention

Study Arms (2)

PAS

EXPERIMENTAL
Device: long-term paired associative stimulation

SHAM

SHAM COMPARATOR
Device: sham long-term paired associative stimulation

Interventions

long-term paired associative stimulationDEVICE

Paired associative stimulation (PAS) administered 3-5 times per week for 4 weeks to upper 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)).

PAS
sham long-term paired associative stimulationDEVICE

Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.

SHAM

Eligibility Criteria

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

You may qualify if:

  • incomplete cervical spinal cord injury
  • time from injury at least 1.5 years
  • chronic SCI- induced neuropathic pain in the upper limb

You may not qualify if:

  • Diagnosed brain damage, visible in MRI or CT.
  • No activity in hands/fingers and no MEPs recorded from distal hand muscles.
  • Epilepsy
  • High intracranial pressure
  • Pacemaker
  • Implanted hearing device
  • Progressive diseases of spinal cord or brain (e.g. malignant tumors, degenerative diseases).
  • Previous head or spinal cord injury affecting the motor performance of upper extremities.
  • Congenital anomaly in the anatomical structure of spinal canal/cord or dura.
  • Significant systemic disease or other condition that could cause neurological deficit, or may affect subject's capability to undergo investigation-related procedures.
  • Acute severe infection.
  • Contraindications for MRI.
  • Current severe psychiatric diseases.
  • Current chronic drug and/or alcohol abuse.
  • Pregnancy.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital

Helsinki, Finland

Location

Related Publications (2)

  • Shulga A, Lioumis P, Kirveskari E, Savolainen S, Makela JP. A novel paired associative stimulation protocol with a high-frequency peripheral component: A review on results in spinal cord injury rehabilitation. Eur J Neurosci. 2021 May;53(9):3242-3257. doi: 10.1111/ejn.15191. Epub 2021 Mar 29.

    PMID: 33738876BACKGROUND

  • Vaalto S, Nyman AL, Shulga A. Analgesic effect of paired associative stimulation in a tetraplegic patient with severe drug-resistant neuropathic pain: a case report. Scand J Pain. 2021 May 21;21(4):831-838. doi: 10.1515/sjpain-2021-0012. Print 2021 Oct 26.

    PMID: 34019752BACKGROUND

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

April 22, 2022

First Posted

May 5, 2022

Study Start

April 22, 2022

Primary Completion

May 22, 2023

Study Completion

September 22, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Locations

FI(1)