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

NCT06239090 | Unknown

• 1 other identifier: NBF2023
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Mood Disorders; Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• Neuropsychological assessment

  For the neuropsychological evaluation, the Brief Repeatable Battery of Neuropsychological Tests is used, which measures cognitive deterioration in patients with multiple sclerosis. The test evaluates memory, attention and learning speed. The higher the score, the better the performance. Administration of the total test battery takes approximately 30 minutes.

  30 minutes

• Mood assessment

  The Beck Depression Inventory is a self-report instrument, composed of 21 items that evaluate the cognitive symptoms, affective, motivational and somatic aspects of depression. Each item is rated on a Likert scale from 0 to 3 points. Scores between 0 and 13 indicate the absence of depressive symptoms; scores between 14 and 18 indicate mild-moderate depression; scores between 19 and 29 indicate moderate-severe depression.

  15 minutes

Study Arms (2)

intervention group (IG)

EXPERIMENTAL

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.

Device: Rehacor-T

sham group (SG)

SHAM COMPARATOR

SG patients will be given irrelevant information (recorded data of other patients) and thus, they cannot modulate their cortical activation.

Behavioral: Sham Intervention

Interventions

Rehacor-T DEVICE

During each session of bio/neurofeedback 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.

intervention group (IG)

Sham Intervention BEHAVIORAL

SG patients will be given irrelevant information (recorded data of other patients) and thus, they cannot modulate their cortical activation and see only the scenarios

sham group (SG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Ascertained diagnosis of multiple pathologies,
• Patients with severe psychotic symptoms;
• Epilepsy;
• Drug use;
• Endocrine-metabolic encephalopathies.
• Presence of multiple therapies

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi Bonino Pulejo

Messina, 98124, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Mood Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 2, 2024
• Study Start: December 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: November 30, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

IT (1)