Study of Brain Activations and Physiological Responses Using NeuroBiofeedback in Patients With Multiple Sclerosis.Study of Brain Activations and Physiological Responses Using NeuroBiofeedback in Patients With Multiple Sclerosis

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Patients aged 18-65 years ;

• Confirmed clinical diagnosis;

• Written informed consent obtained from the patient;

• Moca score ≥ 20;

• Patients with no contraindications to perform MRI and EEG.

• Clinical stability

• documented absence of relapse in the last month before treatment

Locations
Other Locations
Italy
IRCCS Centro Neurolesi Bonino Pulejo
RECRUITING
Messina
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 44
Treatments
Experimental: intervention group (IG)
During each session IG patients will view their recorded brain waves and physiological responses in a computer screen, while a professional will explain to them what they need to do to intervene and make corrective changes to their brain waves.
Sham_comparator: sham group (SG)
SG patients will be given irrelevant information (recorded data of other patients) and thus, they cannot modulate their cortical activation.
Sponsors
Leads: IRCCS Centro Neurolesi Bonino Pulejo

This content was sourced from clinicaltrials.gov