Ignite Creation Date:
2024-05-06 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05086380
Status:
RECRUITING
Last Update Posted:
2023-09-22
First Post:
2021-09-10
Brief Title:
Modulation of Sense of Agency With Non-invasive Brain Stimulation and Mindfulness-based Stress Reduction Therapy
Sponsor:
University of Fribourg
Organization:
University of Fribourg
Study Overview
Official Title:
Modulation of the Sense of Agency Across Different Neurological Disorders Using Non-invasive Brain Stimulation and Mindfulness-based Stress Reduction Therapy
Status:
RECRUITING
Status Verified Date:
2023-09
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:
None
Brief Summary:
A conversion disorder is a dysfunction of the nervous system in which no structural damage can be demonstrated However it must be distinguished from other psychiatric disorders such as psychosis or depression There are a variety of signs of the disease such as muscle paralysis uncontrolled tremors or cramps In rarer cases blindness deafness or numbness may occur Diagnosing this complex disorder has always been a challenge for neurologists and psychiatrists
This study investigates the effects of transcranial magnetic stimulation TMS on the general well-being and symptoms of conversion disorder and other neurological disorders and in comparison to healthy subjects The TMS method allows to target specific areas of the brain by means of magnetic fields This technique is not painful and does not have long-lasting effects
In addition the study investigates the effects of mindfulness-based stress reduction on the general well-being and symptoms of conversion disorder and other neurological disorders and compared to healthy subjects This technique is not painful and has no long-lasting effects
Furthermore the study examines movement patterns and symptoms of patients compared to healthy controls while they are in a virtual reality
Finally the study examines patients brain activity while playing a game targeting the sense of agency in real time which is recorded with an MRI scanner
The study includes a maximum of twelve sessions in total ten sessions of approximately 15-2 hours each and two sessions each overnight The planned study methods include TMS real-time and normal magnetic resonance tomography of the brain MRI tube virtual- and augmented reality ARVR questionnaires blood saliva and motion sensors eg fitness bracelet and participation in the 8-week mindfulness program
This study investigates the effects of transcranial magnetic stimulation TMS on the general well-being and symptoms of conversion disorder and other neurological disorders and in comparison to healthy subjects The TMS method allows to target specific areas of the brain by means of magnetic fields This technique is not painful and does not have long-lasting effects
In addition the study investigates the effects of mindfulness-based stress reduction on the general well-being and symptoms of conversion disorder and other neurological disorders and compared to healthy subjects This technique is not painful and has no long-lasting effects
Furthermore the study examines movement patterns and symptoms of patients compared to healthy controls while they are in a virtual reality
Finally the study examines patients brain activity while playing a game targeting the sense of agency in real time which is recorded with an MRI scanner
The study includes a maximum of twelve sessions in total ten sessions of approximately 15-2 hours each and two sessions each overnight The planned study methods include TMS real-time and normal magnetic resonance tomography of the brain MRI tube virtual- and augmented reality ARVR questionnaires blood saliva and motion sensors eg fitness bracelet and participation in the 8-week mindfulness program
Detailed Description:
None
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