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PAS for Post-SCI Neuropathic Pain

Primary Purpose

Spinal Cord Injury Cervical, Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
long-term paired associative stimulation
sham long-term paired associative stimulation
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury Cervical

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Diagnosed brain damage, visible in MRI or CT.
  • No activity in hands/fingers and no MEPs recorded from distal hand muscles.
  • Epilepsy
  • Metal inclusion in the head area
  • 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.
  • Pressure ulcer affecting the subject's capability to undergo the procedure safely

Sites / Locations

  • Helsinki University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

PAS

SHAM

Arm Description

Outcomes

Primary Outcome Measures

Brief Pain Inventory
0-10 scale, 0 - no pain, 10 - worst possible pain.
Brief Pain Inventory
0-10 scale, 0 - no pain, 10 - worst possible pain.
Numeric Rating Scale
0-10 scale, 0 - no pain, 10 - worst possible pain.
Numeric Rating Scale
0-10 scale, 0 - no pain, 10 - worst possible pain.

Secondary Outcome Measures

Full Information

First Posted
April 22, 2022
Last Updated
September 22, 2023
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05362422
Brief Title
PAS for Post-SCI Neuropathic Pain
Official Title
Paired Associative Stimulation for Post- Spinal Cord Injury Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
May 22, 2023 (Actual)
Study Completion Date
September 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury Cervical, Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PAS
Arm Type
Experimental
Arm Title
SHAM
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
long-term paired associative stimulation
Intervention Description
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)).
Intervention Type
Device
Intervention Name(s)
sham long-term paired associative stimulation
Intervention Description
Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.
Primary Outcome Measure Information:
Title
Brief Pain Inventory
Description
0-10 scale, 0 - no pain, 10 - worst possible pain.
Time Frame
Change from baseline at 1 day after the intervention
Title
Brief Pain Inventory
Description
0-10 scale, 0 - no pain, 10 - worst possible pain.
Time Frame
Change from baseline at 8 weeks after the intervention
Title
Numeric Rating Scale
Description
0-10 scale, 0 - no pain, 10 - worst possible pain.
Time Frame
Change from baseline at 1 day after the intervention
Title
Numeric Rating Scale
Description
0-10 scale, 0 - no pain, 10 - worst possible pain.
Time Frame
Change from baseline at 8 weeks after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: incomplete cervical spinal cord injury time from injury at least 1.5 years chronic SCI- induced neuropathic pain in the upper limb Exclusion Criteria: Diagnosed brain damage, visible in MRI or CT. No activity in hands/fingers and no MEPs recorded from distal hand muscles. Epilepsy Metal inclusion in the head area 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. Pressure ulcer affecting the subject's capability to undergo the procedure safely
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33738876
Citation
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.
Results Reference
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PubMed Identifier
34019752
Citation
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.
Results Reference
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PAS for Post-SCI Neuropathic Pain

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