Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06214208
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-01-09
Brief Title:
Influence of Spinal Stimulation Frequency on Spasticity Motor Control and Pain After Spinal Cord Injury
Sponsor:
Shepherd Center Atlanta GA
Organization:
Shepherd Center Atlanta GA
Study Overview
Official Title:
Neuromodulation of Spinal Circuits Effects on Spasticity Nociception and Motor Activation Phase II
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The goal of this study is to identify the effect of different types of noninvasive spinal stimulation on spasticity involuntary muscle activity muscle strength and pain in people with spinal cord injury The spinal stimulation consists of electrical stimulation applied through one electrode over the skin of the lower back and two electrodes over the stomach Testing will include participating in measurements before the intervention during intervention and immediately after the intervention This study requires participants to come into Shepherd Center 4 consecutive days a week for 2-3 hours per day across 2-3 weeks
Detailed Description:
Transcutaneous spinal stimulation TSS is a noninvasive electrical stimulation that is applied over the skin of the low back and stomach In prior research studies TSS has reduced spasticity without the negative side effects of drug therapies Although research in TSS is growing the best dosage of TSS remains unknown The investigators want to further advance the effects of TSS by comparing three different frequencies Frequency is the number of electrical pulses that are delivered over a period of time Frequency can affect the activation of nerves and therefore affect the outcome of TSS Participation in this study includes testing of the participants spasticity strength and pain before and after 30 minutes of TSS
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HD101812-01A1 | NIH | None | httpsreporternihgovquickSearch1R01HD101812-01A1 |