PAS for Post-SCI Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

Paired Associative Stimulation for Post- Spinal Cord Injury Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05362422
• Other study ID #: TYH2020244
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Spinal Cord Injuries
• Spinal Cord Injury Cervical

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