Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04506099
Status:
WITHDRAWN
Last Update Posted:
2021-10-22
First Post:
2020-07-16
Brief Title:
Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of study staff
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TINS
Brief Summary:
The purpose of this study is to determine the safety feasibility and effectiveness of electric stimulation of the nerves along the intercostal nerves on pain and spasticity in spinal cord injury patients
Detailed Description:
Neuromodulation techniques are safely used as a treatment for neuropathic pain in chronic SCI Neuromodulation techniques have also been safely and successfully used to strengthen the abdomen in stroke patients10 Most similar to our TINS protocol is transcutaneous tibial nerve stimulation TTNS which has shown to mitigate the development of neurogenic bladder in acute SCI6 However neuromodulation is rarely performed in acute SCI and to our knowledge neuromodulation has not been performed to prevent the development of chronic neuropathic pain There has been little published regarding the effects of electric stimulation upon the trunk in acute SCI as a prevention for chronic neuropathic pain and spasticity Gaps in the knowledge which we intend to fill are
1 Safety and feasibility of TINS in acute SCI during inpatient rehabilitation
2 Effectiveness of a 2-week TINS protocol in acute SCI based on changes between admission discharge and weekly numerical pain scores and spasticity questionnaire scores in those with TINS compared to sham TINS for 2-months
3 Analysis of neuropathic pain medication dosages in those with and without TINS at admission discharge and 2 months post-discharge and evaluation of morbidity at 2- months post-discharge
1 Safety and feasibility of TINS in acute SCI during inpatient rehabilitation
2 Effectiveness of a 2-week TINS protocol in acute SCI based on changes between admission discharge and weekly numerical pain scores and spasticity questionnaire scores in those with TINS compared to sham TINS for 2-months
3 Analysis of neuropathic pain medication dosages in those with and without TINS at admission discharge and 2 months post-discharge and evaluation of morbidity at 2- months post-discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None