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Random Noise Stimulation to Enhance Cortical Drive & Improve Hand Function

Primary Purpose

Spinal Cord Injuries, Tetraplegia, Cervical Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial Random Noise Stimulation (tRNS)
transcranial Direct Current Stimulation (tDCS)
sham-stimulation
Sponsored by
Shepherd Center, Atlanta GA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Non-invasive brain stimulation, Hand function, Random noise

Eligibility Criteria

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

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • Shepherd Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

transcranial Random Noise Stimulation (tRNS)

transcranial Direct Current Stimulation (tDCS)

Arm Description

Participants in this group will receive a combined intervention (3 days of tRNS during functional task practice and 3 days of sham-stimulation during functional task practice).

Participants in this group will receive a combined intervention (3 days of tDCS during functional task practice and 3 days of sham-stimulation during functional task practice).

Outcomes

Primary Outcome Measures

Change in Cortical excitability
The communication between brain and spinal cord will be evaluated. Sensors that detect muscle activity will be placed over hand muscles. Pulses of stimulation will be applied to the head using a type of non-invasive brain stimulation called transcranial magnetic stimulation (TMS). The size of the muscle response will be recorded.
Change in Strength (key pinch and grasp strength)
Key pinch and grasp strength will be assessed using a dynamometer.
Change in Sensory function (sensation subtest of the Graded Redefined Assessment of Strength Sensibility and Prehension)
Semmes and Weinstein Monofilaments will be applied on 3 dorsal and palmar sensory test locations in each hand. Each location is scored from 0 to 4.

Secondary Outcome Measures

Change in Unimanual function (Grasp and Release Test)
Participants will be required to grasp, move, and release six objects of different size and weight. For each task, the number of successful and unsuccessful attempts is 30s will be recorded.
Change in Bimanual function (Chedoke Arm and Hand Activity Inventory)
This test consists of 9 functional tasks that require bimanual coordination. Each item is graded on a 7-point activity scale with higher scores suggesting better bimanual function.
Change in Sensory Function (revised Nottingham Sensory Assessment)
Tactile sensation, proprioception, stereognosis, and two-point discrimination will be tested. Higher scores indicate better sensory function.

Full Information

First Posted
February 25, 2021
Last Updated
October 24, 2022
Sponsor
Shepherd Center, Atlanta GA
Collaborators
The Craig H. Neilsen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04777149
Brief Title
Random Noise Stimulation to Enhance Cortical Drive & Improve Hand Function
Official Title
Random Noise Stimulation to Enhance Corticomotor Drive for Improved Hand Function
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
August 10, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shepherd Center, Atlanta GA
Collaborators
The Craig H. Neilsen Foundation

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
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. Recent approaches that involve the application of non-invasive brain stimulation have the potential to strengthen the remaining connections between the brain and the spinal cord for improved hand function. Combining brain stimulation with performing upper limb functional tasks may further increase the ability of individuals with tetraplegia to use their hands. The purpose of this study is to investigate if "random noise", a special type of brain stimulation that most people cannot feel, can be used to enhance upper limb function in individuals with spinal cord injury. Specifically, the investigators will examine if a combined treatment protocol of random noise and fine motor training results in greater improvements in motor and sensory hand function compared to fine motor training alone.
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 duration of non-invasive brain stimulation (NIBS) can strengthen the transmission of information through the spared corticospinal pathways and improve UE functional recovery in individuals with tetraplegia. Transcranial direct current stimulation (tDCS), which is a clinically accessible NIBS approach, has been used to modulate cortical plasticity and improve hand function. However, the high variability in the reported effects of tDCS raises questions about its clinical value and highlights the need to investigate more robust NIBS protocols. Transcranial random noise stimulation (tRNS) is a novel NIBS approach that produces more consistent facilitatory effects compared to tDCS. TRNS delivers a low alternating current with a continuously changing intensity over a wide frequency range. Further, tRNS has excellent tolerability and no risk of skin burns since it is a polarity independent stimulation approach. When tRNS is applied over the motor cortex, it increases cortical excitability in the hand representation area and enhances motor learning in healthy adults. Despite the potential promise of tRNS in increasing corticomotor drive for improved motor performance, its application in persons with SCI is novel. Therefore, in this study, the investigators propose to use tRNS to augment the therapeutic effects of functional task practice (FTP). Our aim is to compare the efficacy of a 3-day tRNS+FTP protocol on cortical excitability, UE motor, and sensory function to tDCS+FTP and to sham-stimulation+FTP in individuals with tetraplegia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Tetraplegia, Cervical Spinal Cord Injury
Keywords
Non-invasive brain stimulation, Hand function, Random noise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Wash-in control design
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transcranial Random Noise Stimulation (tRNS)
Arm Type
Experimental
Arm Description
Participants in this group will receive a combined intervention (3 days of tRNS during functional task practice and 3 days of sham-stimulation during functional task practice).
Arm Title
transcranial Direct Current Stimulation (tDCS)
Arm Type
Active Comparator
Arm Description
Participants in this group will receive a combined intervention (3 days of tDCS during functional task practice and 3 days of sham-stimulation during functional task practice).
Intervention Type
Other
Intervention Name(s)
transcranial Random Noise Stimulation (tRNS)
Intervention Description
Two electrodes will be placed over the targeted areas on participant's head. A current of random frequency and intensity will be delivered. TRNS will be applied during the first 20 min of functional task practice.
Intervention Type
Other
Intervention Name(s)
transcranial Direct Current Stimulation (tDCS)
Intervention Description
Two electrodes will be placed over the targeted areas on participant's head. A continuous low intensity current will be delivered. TDCS will be applied during the first 20 min of functional task practice.
Intervention Type
Other
Intervention Name(s)
sham-stimulation
Intervention Description
Two electrodes will be placed over the targeted areas on participant's head. A continuous low intensity current will be delivered for 1- 2 min.
Primary Outcome Measure Information:
Title
Change in Cortical excitability
Description
The communication between brain and spinal cord will be evaluated. Sensors that detect muscle activity will be placed over hand muscles. Pulses of stimulation will be applied to the head using a type of non-invasive brain stimulation called transcranial magnetic stimulation (TMS). The size of the muscle response will be recorded.
Time Frame
Baseline; Post Testing Week 1; Post Testing Week 2
Title
Change in Strength (key pinch and grasp strength)
Description
Key pinch and grasp strength will be assessed using a dynamometer.
Time Frame
Baseline; Post Testing Week 1; Post Testing Week 2
Title
Change in Sensory function (sensation subtest of the Graded Redefined Assessment of Strength Sensibility and Prehension)
Description
Semmes and Weinstein Monofilaments will be applied on 3 dorsal and palmar sensory test locations in each hand. Each location is scored from 0 to 4.
Time Frame
Baseline; Post Testing Week 1; Post Testing Week 2
Secondary Outcome Measure Information:
Title
Change in Unimanual function (Grasp and Release Test)
Description
Participants will be required to grasp, move, and release six objects of different size and weight. For each task, the number of successful and unsuccessful attempts is 30s will be recorded.
Time Frame
Baseline; Post Testing Week 1; Post Testing Week 2
Title
Change in Bimanual function (Chedoke Arm and Hand Activity Inventory)
Description
This test consists of 9 functional tasks that require bimanual coordination. Each item is graded on a 7-point activity scale with higher scores suggesting better bimanual function.
Time Frame
Baseline; Post Testing Week 1; Post Testing Week 2
Title
Change in Sensory Function (revised Nottingham Sensory Assessment)
Description
Tactile sensation, proprioception, stereognosis, and two-point discrimination will be tested. Higher scores indicate better sensory function.
Time Frame
Baseline; Post Testing Week 1; Post Testing Week 2

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: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasia Zarkou, PT,MS,PhD
Organizational Affiliation
Shepherd Center, Atlanta GA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States

12. IPD Sharing Statement

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Random Noise Stimulation to Enhance Cortical Drive & Improve Hand Function

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