Status:

COMPLETED

Random Noise Stimulation to Enhance Cortical Drive & Improve Hand Function

Lead Sponsor:

Shepherd Center, Atlanta GA

Collaborating Sponsors:

The Craig H. Neilsen Foundation

Conditions:

Spinal Cord Injuries

Tetraplegia

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

Cervical spinal cord injury (SCI) results in hand and arm function impairments and decreased independence in performance of daily activities such as bathing, eating, dressing, writing, or typing. Rece...

Detailed Description

Cervical spinal cord injury (SCI) results in upper extremity (UE) functional impairments that can restrict independence, social participation, and overall quality of life. Evidence shows that short du...

Eligibility Criteria

Inclusion

  • Spinal Cord Injury level above C8
  • ASIA Impairment Scale (AIS) classification level: C, D
  • Time since injury: ≥ 1 year
  • Active intrinsic hand muscles in at least one UE
  • Active extrinsic hand muscles in both UE
  • Ability to follow multiple step commands
  • Ability to communicate pain or discomfort
  • Willingness to participate in testing
  • Ability to obtain informed consent

Exclusion

  • Implanted metallic device in the head and/ or pacemaker
  • History of seizures
  • History of severe headaches
  • Severe contractures of UE that would limit participation in FTP
  • Prior tendon or nerve transfer surgery
  • Received Botulinum toxin injection in the tested UE in the last 3 months
  • Pregnancy

Key Trial Info

Start Date :

April 12 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 10 2022

Estimated Enrollment :

19 Patients enrolled

Trial Details

Trial ID

NCT04777149

Start Date

April 12 2021

End Date

August 10 2022

Last Update

October 26 2022

Active Locations (1)

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1

Shepherd Center

Atlanta, Georgia, United States, 30309