Random Noise Stimulation to Enhance Cortical Drive & Improve Hand Function

Random Noise Stimulation to Enhance Corticomotor Drive for Improved Hand Function

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Cervical Spinal Cord Injury; Tetraplegia
• Intervention / Treatment: Other: transcranial Random Noise Stimulation (tRNS); Other: sham-stimulation; Other: transcranial Direct Current Stimulation (tDCS)

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Shepherd Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: transcranial Random Noise Stimulation (tRNS); 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).	Other: transcranial Random Noise Stimulation (tRNS); 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.; Other: sham-stimulation; 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.
Active Comparator: transcranial Direct Current Stimulation (tDCS); 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).	Other: sham-stimulation; 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.; Other: transcranial Direct Current Stimulation (tDCS); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline; Post Testing Week 1; Post Testing Week 2
Change in Strength (key pinch and grasp strength)	Key pinch and grasp strength will be assessed using a dynamometer.	Baseline; Post Testing Week 1; Post Testing Week 2
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.	Baseline; Post Testing Week 1; Post Testing Week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline; Post Testing Week 1; Post Testing Week 2
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.	Baseline; Post Testing Week 1; Post Testing Week 2
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.	Baseline; Post Testing Week 1; Post Testing Week 2

Collaborators and Investigators

• Sponsor: Shepherd Center, Atlanta GA
• Collaborators: The Craig H. Neilsen Foundation
• Investigators: Principal Investigator: Anastasia Zarkou, PT,MS,PhD, Shepherd Center, Atlanta GA

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): August 10, 2022
• Study Completion (Actual): August 10, 2022

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Hand function; Non-invasive brain stimulation; Random noise
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Wounds and Injuries; Spinal Cord Injuries; Quadriplegia
• Other Study ID Numbers: 762

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No