PAS for Post-SCI Neuropathic Pain

NCT ID: NCT05362422

Last Updated: 2023-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-22

Study Completion Date

2023-09-22

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injury Cervical Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PAS

Group Type EXPERIMENTAL

long-term paired associative stimulation

Intervention Type DEVICE

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)).

SHAM

Group Type SHAM_COMPARATOR

sham long-term paired associative stimulation

Intervention Type DEVICE

Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.

Interventions

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long-term paired associative stimulation

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

sham long-term paired associative stimulation

Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anastasia Shulga

Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helsinki University Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type BACKGROUND
PMID: 33738876 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34019752 (View on PubMed)

Other Identifiers

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TYH2020244

Identifier Type: -

Identifier Source: org_study_id

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