Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432686
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-22
Brief Title:
Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS - a Pilot Study
Status:
NOT_YET_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:
Transcutaneous Electrical Nerve Stimulation TENS is a treatment that could potentially reduce walking problems and fatigue in persons with Multiple Sclerosis However extensive use of TENS in a clinical setting is hindered by a lack of neurophysiological understanding of the effects of TENS The primary objective of this pilot study is therefore to investigate the effects of TENS on brain activity in pwMS measured with fMRI
Detailed Description:
This study is an exploratory study to see if we can detect changes in fMRI activity during TENS in persons with MS This is a randomized single-blind crossover design Subjects will undergo an MRI scan while they receive sham stimulation of the tibialis anterior active stimulation of the tibialis anterior stimulation of the quadriceps perform continuous movements of the foot plantar dorsiflexion and a combination of stimulation of the tibialis anterior and movement of the foot This study will include 15 subjects with relapsing remitting or progressive MS and 15 healthy controls Blood-oxygen-level-dependent BOLD activation changes and the interaction networks before during and after active TENS and differences in activation due to stimulation on quadriceps vs tibialis anterior stimulation on tibialis anterior vs plantardorsiflexion and stimulation on tibialis anterior vs stimulation combined with plantardorsiflexion This will be compared between pwMS and healthy controls This study can add to the limited knowledge and possibly help to personalize and implement TENS in the clinic
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?:
False
Is an FDA AA801 Violation?:
None