Multiple SclerosisNBF2023NCT06239090
Study of Brain Activations and Physiological Responses Using NeuroBiofeedback in Patients With Multiple Sclerosis
A study testing Rehacor-T in people with Multiple Sclerosis and Mood Disorders, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Mood Disorders, Cognitive Impairment
- What is being tested?
- Rehacor-T
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2023to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Ascertained diagnosis of multiple pathologies,
- Patients with severe psychotic symptoms;
- Epilepsy;
- Drug use;
- Endocrine-metabolic encephalopathies.
- Presence of multiple therapies
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Centro Neurolesi Bonino Pulejo
Messina, 98124
Giuseppa Maresca, dr, +3909060128179, giusy.maresca@irccsme.it
About this study
Official title: 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
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.
Read the 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
- Conditions
- Multiple Sclerosis, Mood Disorders, Cognitive Impairment
- Being tested
- Rehacor-T, Sham Intervention
- Medical subject headings
- Multiple Sclerosis, Mood Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehacor-TDevice
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.
Sham InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sham Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Dec 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppa Maresca, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239090
- Sponsor's protocol ID
- NBF2023
- Acronym
- NBF2023
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06239090
- Acronym / sponsor ID
- NBF2023 / NBF2023
- Conditions
- Multiple Sclerosis, Mood Disorders, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group (IG) | Experimental | Device: Rehacor-TDuring 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 group (SG) | Sham comparator | Behavioral: Sham InterventionSG patients will be given irrelevant information (recorded data of other patients) and thus, they cannot modulate their cortical activation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- Ascertained diagnosis of multiple pathologies,
- Patients with severe psychotic symptoms;
- Epilepsy;
- Drug use;
- Endocrine-metabolic encephalopathies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehacor-TDuring 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. | Device | intervention group (IG) |
| Sham InterventionSG patients will be given irrelevant information (recorded data of other patients) and thus, they cannot modulate their cortical activation and see only the scenarios | Behavioural | sham group (SG) |
Primary outcome
Neuropsychological assessment
Time frame: 30 minutes
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.
Mood assessment
Time frame: 15 minutes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
Related trials for Multiple Sclerosis
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
RecruitingObservational study
Aerobic Fitness in Multiple Sclerosis: The Relationship Between Balance and Sensory Dual-Tasking
Multiple Sclerosis
Recruiting
HOBSCOTCH-MS-Efficacy Trial
Multiple Sclerosis, Cognitive Dysfunction
RecruitingPhase 1/2
A Study of AZD0120 in Autoimmune Diseases
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehacor-T in people with Multiple Sclerosis and Mood Disorders, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological assessment (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.