Ignite Creation Date:
2024-05-05 @ 10:25 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01106365
Status:
COMPLETED
Last Update Posted:
2021-07-29
First Post:
2010-04-16
Brief Title:
Repetitive Deep Transcranial Magnetic Stimulation in Multiple Sclerosis
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Repetitive Deep Transcranial Magnetic Stimulation in Multiple Sclerosis - A Pilot Study to Evaluate Safety and Efficacy of Deep rTMS on Fatigue and Depressivity in Patients With Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2021-07
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:
rTMS in MS
Brief Summary:
Multiple sclerosis MS is a chronic-inflammatory autoimmune central nervous system disorder and a leading cause of neurological disability in younger adults in Western countries Besides classic neurological symptoms both depressivity and fatigue are among the most frequent symptoms in MS affecting up to 90 of patients at onset or during the course of the disease Neither are the psychological and immunological backgrounds of both well understood nor are there numerous controlled therapeutic trials which would offer convincing treatment options for fatigue and depressivity in MS
Transcranial magnetic stimulation TMS has been frequently used to investigate altered hemispheric and inter-hemispheric connectivity in MS Recently first therapeutic trials have been performed to address specific MS-related symptoms by TMS Koch et al demonstrated an improvement of hand dexterity following repetitive TMS and Centonze and colleagues showed reduced spasticity following TMS
Recently a specific coil for the stimulation of deeper brain regions including the deep nuclei was developed the so-called H-coil It successfully stimulates deeper pre-frontal brain regions Stimulation with this coil has been shown to be safe and well tolerated in healthy volunteers and in patients suffering from major depression
The aim of this project is to apply deep TMS with the H-coil to the prefrontal cortex PFC of MS patients The PFC is the region at which stimulation is aimed in previous depression studies as this brain region has been shown to play a relevant role in affective disorders It is the primary aim of this study to evaluate the safety and tolerability of deep TMS with the H-coil in MS patients with fatigue or depressivity
Transcranial magnetic stimulation TMS has been frequently used to investigate altered hemispheric and inter-hemispheric connectivity in MS Recently first therapeutic trials have been performed to address specific MS-related symptoms by TMS Koch et al demonstrated an improvement of hand dexterity following repetitive TMS and Centonze and colleagues showed reduced spasticity following TMS
Recently a specific coil for the stimulation of deeper brain regions including the deep nuclei was developed the so-called H-coil It successfully stimulates deeper pre-frontal brain regions Stimulation with this coil has been shown to be safe and well tolerated in healthy volunteers and in patients suffering from major depression
The aim of this project is to apply deep TMS with the H-coil to the prefrontal cortex PFC of MS patients The PFC is the region at which stimulation is aimed in previous depression studies as this brain region has been shown to play a relevant role in affective disorders It is the primary aim of this study to evaluate the safety and tolerability of deep TMS with the H-coil in MS patients with fatigue or depressivity
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None