Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777149
Status:
COMPLETED
Last Update Posted:
2022-10-26
First Post:
2021-02-25
Brief Title:
Random Noise Stimulation to Enhance Cortical Drive Improve Hand Function
Sponsor:
Shepherd Center Atlanta GA
Organization:
Shepherd Center Atlanta GA
Study Overview
Official Title:
Random Noise Stimulation to Enhance Corticomotor Drive for Improved Hand Function
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 tRNSFTP protocol on cortical excitability UE motor and sensory function to tDCSFTP and to sham-stimulationFTP in individuals with tetraplegia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None