Ignite Creation Date:
2024-05-06 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05226676
Status:
WITHDRAWN
Last Update Posted:
2023-08-04
First Post:
2022-01-26
Brief Title:
Long-term Effects of Repetitive TMS in Chronic Neuropathic Pain in People With SCI
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Long-term Effects of Repetitive TMS in Chronic Neuropathic Pain in People With SCI
Status:
WITHDRAWN
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The PI left the institution and the study couldnt be transfer to a new PI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Around 80 of people with spinal cord injury SCI develop chronic neuropathic pain CNP This is a debilitating condition with major negative impacts on peoples quality of life Many treatment options have been offered invasive stimulation drugs but provide limited effects and many secondary effects There is a critical need to develop a new generation of therapies Transcranial magnetic stimulation TMS is a non-invasive and painless brain stimulation technique that allows researchers to explore and change brain excitability that has shown promising effects in neuropathic pain However there is not enough evidence of what are the long lasting effects of the different protocols In this study 30 SCI subjects with CNP in their hands will participate in the study The objective is to evaluate the efficacy of real versus sham repetitive transcranial magnetic stimulation rTMS and investigate 1 short and long term effects on pain and 2 the behavioral and neurophysiological qualities of responders and non-responders to this treatmentThis will be a randomized sham controlled trial with two groups real or sham high frequency repetitive TMS protocol 20Hz The protocol will be done daily for two weeks Clinical functional and neurophysiological evaluations will be assessed at baseline post intervention and at 6-week follow up
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 19-1382-00001-01-PD | OTHER_GRANT | New York State Department Of Health | None |