Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-27 @ 10:46 PM
Study NCT ID:
NCT07202195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
At Home Use of Stimulation Suits for Managing MS Symptoms
Sponsor:
Daphne Kos
Organization:
Study Overview
Official Title:
Home-Based Neuromodulation Suits for Reducing Spasticity and Ataxia in Multiple Sclerosis: A Multi-center RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
HANDS-MS
Brief Summary:
This study is being carried out at Multiple Sclerosis (MS) centers to evaluate whether a full-body stimulation suit at home can help people with Multiple Sclerosis (pwMS) reduce symptoms like spasticity (muscle stiffness) and ataxia (poor coordination), and improve daily functioning.
Can pwMS who experience spasticity or ataxia benefit from using a stimulation suit for 6 weeks?
Researchers will compare two groups: an intervention group (who will use the suit) and a control group (who will not use the suit).
Participants in the intervention group will:
* Wear the suit for 6 weeks in total every day or every other day (1 week during their MS center admission and 5 weeks at home).
* Receive their usual care in addition to wearing the suit.
* Undergo clinical tests at the MS center after 1 week and 6 weeks of stimulation.
Participants in the control group will:
* Receive their usual care.
* Undergo clincial tests at the same time points as the other group.
Can pwMS who experience spasticity or ataxia benefit from using a stimulation suit for 6 weeks?
Researchers will compare two groups: an intervention group (who will use the suit) and a control group (who will not use the suit).
Participants in the intervention group will:
* Wear the suit for 6 weeks in total every day or every other day (1 week during their MS center admission and 5 weeks at home).
* Receive their usual care in addition to wearing the suit.
* Undergo clinical tests at the MS center after 1 week and 6 weeks of stimulation.
Participants in the control group will:
* Receive their usual care.
* Undergo clincial tests at the same time points as the other group.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: