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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05362422
Other study ID # TYH2020244
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 22, 2022
Est. completion date September 22, 2023

Study information

Verified date September 2023
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date September 22, 2023
Est. primary completion date May 22, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Device:
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)).
sham long-term paired associative stimulation
Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.

Locations

Country Name City State
Finland Helsinki University Hospital Helsinki

Sponsors (1)

Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Brief Pain Inventory 0-10 scale, 0 - no pain, 10 - worst possible pain. Change from baseline at 1 day after the intervention
Primary Brief Pain Inventory 0-10 scale, 0 - no pain, 10 - worst possible pain. Change from baseline at 8 weeks after the intervention
Primary Numeric Rating Scale 0-10 scale, 0 - no pain, 10 - worst possible pain. Change from baseline at 1 day after the intervention
Primary Numeric Rating Scale 0-10 scale, 0 - no pain, 10 - worst possible pain. Change from baseline at 8 weeks after the intervention
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