Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06239090
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2024-01-09
Brief Title:
Study of Brain Activations and Physiological Responses Using NeuroBiofeedback in Patients With Multiple Sclerosis
Sponsor:
IRCCS Centro Neurolesi Bonino-Pulejo
Organization:
IRCCS Centro Neurolesi Bonino-Pulejo
Study Overview
Official Title:
Study of Brain Activations and Physiological Responses Using NeuroBiofeedback in Patients With Multiple SclerosisStudy of Brain Activations and Physiological Responses Using NeuroBiofeedback in Patients With Multiple Sclerosis
Status:
RECRUITING
Status Verified Date:
2024-01
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:
NBF2023
Brief Summary:
Multiple sclerosis MS is a chronic autoimmune disease of the central nervous system CNS characterized by inflammation demyelination gliosis and neuronal loss Neurological symptoms may include visual disturbances numbness and tingling focal weakness bladder and bowel incontinence and cognitive impairment Some previous studies have indicated that the NeuroBiofeedback NBF technique could be a promising new treatment for the rehabilitation of many neurological disorders and neurodegenerative diseases including MS Several studies have investigated the beneficial effects of this technique on the motor and cognitive outcomes of MS mainly aiming to evaluate motor performance fatigue and chronic pain Few studies have focused on the evaluation and treatment of cognitive processes with NBF except for one study on information processing speed Specifically regarding the application of NBF techniques in MS recent literature has demonstrated that modulation of the alpha-theta rhythm has led to an improvement in attentional processes with consequent reduction in anxiety Therefore the objective of this study is to verify the effectiveness of NBF training on the modulation of cortical activity and physiological responses through the exposure of subjects with MS to cognitive tasks and training for mood regulation
Detailed Description:
Multiple sclerosis MS is a chronic autoimmune disease of the central nervous system CNS characterized by inflammation demyelination gliosis and neuronal loss Neurological symptoms may include visual disturbances numbness and tingling focal weakness bladder and bowel incontinence and cognitive impairment Some previous studies have indicated that the NeuroBiofeedback NBF technique could be a promising new treatment for the rehabilitation of many neurological disorders and neurodegenerative diseases including MS Several studies have investigated the beneficial effects of this technique on the motor and cognitive outcomes of MS mainly aiming to evaluate motor performance fatigue and chronic pain Few studies have focused on the evaluation and treatment of cognitive processes with NBF except for one study on information processing speed Specifically regarding the application of NBF techniques in MS recent literature has demonstrated that modulation of the alpha-theta rhythm has led to an improvement in attentional processes with consequent reduction in anxiety Therefore the objective of this study is to verify the effectiveness of NBF training on the modulation of cortical activity and physiological responses through the exposure of subjects with MS to cognitive tasks and training for mood regulation
Patients will not undergo an experimental procedure as foreseen by the study the clinical and neuropsychological variables that will be collected for the study are those that are commonly collected by the neuropsychologist in particular the main neuro-cognitive functions memory language attention and executive functioning and emotional abilities meta cognition will be considered After enrollment the clinical background and baseline characteristics of patients will be assessed Enrolled patients will be randomly assigned to IG and SG After randomization patients will undergo instrumental examinations and neuropsychological evaluation as required by the protocol Patients in both groups will undergo 2 neurofeedback training sessions All recruited subjects will be evaluated at two time-points a first evaluation at baseline T0 and at the end of the training T1 Patients will undergo stimulation training via NBF 2 times a week for two months for a total of 16 sessions The procedure and execution of the training requires that the subjects are connected to a series of electrodes that will record the cortical electrical activity During each session IG patients will view their recorded brain waves and physiological responses in front of a computer screen while a professional will explain to them what they need to do to intervene on what they see in order to correctively modify their brain waves While SG patients will be provided with irrelevant information recorded data from other patients and therefore will not be able to modulate their cortical activation
Patients will not undergo an experimental procedure as foreseen by the study the clinical and neuropsychological variables that will be collected for the study are those that are commonly collected by the neuropsychologist in particular the main neuro-cognitive functions memory language attention and executive functioning and emotional abilities meta cognition will be considered After enrollment the clinical background and baseline characteristics of patients will be assessed Enrolled patients will be randomly assigned to IG and SG After randomization patients will undergo instrumental examinations and neuropsychological evaluation as required by the protocol Patients in both groups will undergo 2 neurofeedback training sessions All recruited subjects will be evaluated at two time-points a first evaluation at baseline T0 and at the end of the training T1 Patients will undergo stimulation training via NBF 2 times a week for two months for a total of 16 sessions The procedure and execution of the training requires that the subjects are connected to a series of electrodes that will record the cortical electrical activity During each session IG patients will view their recorded brain waves and physiological responses in front of a computer screen while a professional will explain to them what they need to do to intervene on what they see in order to correctively modify their brain waves While SG patients will be provided with irrelevant information recorded data from other patients and therefore will not be able to modulate their cortical activation
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