Random Noise Stimulation to Enhance Cortical Drive & Improve Hand Function
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 2, 2021
CompletedStudy Start
First participant enrolled
April 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2022
CompletedOctober 26, 2022
October 1, 2022
1.3 years
February 25, 2021
October 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Change in Unimanual function (Grasp and Release Test)
Baseline; Post Testing Week 1; Post Testing Week 2
Change in Bimanual function (Chedoke Arm and Hand Activity Inventory)
Baseline; Post Testing Week 1; Post Testing Week 2
Change in Sensory Function (revised Nottingham Sensory Assessment)
Baseline; Post Testing Week 1; Post Testing Week 2
Study Arms (2)
transcranial Random Noise Stimulation (tRNS)
EXPERIMENTALParticipants 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).
transcranial Direct Current Stimulation (tDCS)
ACTIVE COMPARATORParticipants 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).
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shepherd Center, Atlanta GAlead
- The Craig H. Neilsen Foundationcollaborator
Study Sites (1)
Shepherd Center
Atlanta, Georgia, 30309, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anastasia Zarkou, PT,MS,PhD
Shepherd Center, Atlanta GA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2021
First Posted
March 2, 2021
Study Start
April 12, 2021
Primary Completion
August 10, 2022
Study Completion
August 10, 2022
Last Updated
October 26, 2022
Record last verified: 2022-10