Cognitive Abilities in Brain Damaged Patients

NCT ID: NCT03344731

Last Updated: 2022-10-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-15
• Study Completion Date: 2025-12-31

Brief Summary

The presence of damage to the central and / or peripheral nervous system resulting from pathologies of a different nature (such as multiple sclerosis, Parkinson's disease, dementia, cranial trauma, stroke, epilepsy or other neurological syndromes) is commonly a cause of physical and mental disability. The presence of memory or language cognitive deficits is often evident at a first clinical examination. However, difficulties in cognitive areas such as decision-making, social and emotional cognition or particular forms of learning may be less evident, while exerting a strong impact on the quality of life of patients.

The main purpose of this proposal is to investigate cognitive abilities in patients with neurological damage, through a series of specific tasks.

In addition, the contribution of specific brain areas to the cognitive tasks will be assessed by direct modulation of brain activity. This modulation will be achieved by using non-invasive brain stimulation techniques such as Transcranial Magnetic Stimulation (TMS) and Direct Transcranial Electric Stimulation (tDCS).

Detailed Description

The presence of damage to the central and / or peripheral nervous system resulting from pathologies of a different nature (such as multiple sclerosis, Parkinson's disease, dementia, cranial trauma, stroke, epilepsy or other neurological syndromes) is commonly a cause of physical and mental disability. The presence of memory or language cognitive deficits is often evident at a first clinical examination. However, difficulties in cognitive areas such as decision-making, social and emotional cognition or particular forms of learning may be less evident, while exerting a strong impact on the quality of life of patients.

The main purpose of this proposal is to investigate cognitive abilities in patients with neurological damage, through a series of specific tasks. To this end, a series of tests and questionnaires will be used, described in detail below, to evaluate various cognitive functions, including decision-making, problem-solving, learning, memory, executive, social and emotional cognition.

In addition, the contribution of specific brain areas to the cognitive tasks will be assessed by direct modulation of brain activity. This modulation will be achieved by using non-invasive brain stimulation techniques such as Transcranial Magnetic Stimulation (TMS) and Direct Transcranial Electric Stimulation (tDCS).

TMS, in particular, is a non-invasive neuronal stimulation of surface areas of the brain that since its inception has been frequently used in neurology as a diagnostic and research tool. TMS uses magnetic fields to induce electrical currents that facilitate or inhibit cortical activity. TDCS consists in the application of weak electrical currents to generate an electric field that can modulate neural activity in an excitatory or inhibitory manner. TMS and tDCS can be used in the experimental field to modulate cortical activity and modify performance during cognitive tasks.

An important mechanism responsible for clinical, cognitive and functional recovery after neurological damage of different types is synaptic plasticity. Nervous tissue has the ability to permanently enhance or de-energize inter-neuronal transmission at synaptic level. By increasing the efficiency of synaptic transmission, through a phenomenon known as long-term potentiation (LTP), it is possible to compensate the loss of synaptic pulses on survived neurons due to brain damage and restore their function. LTP is also capable of guiding the formation of new brain circuits (structural plasticity), with compensatory and adaptive function . Indeed, neurotransmitters, in addition to their bioelectric conduction activity, also act on neurotrophic factors.

Aim The aim of this study is to evaluate cognitive abilities in healthy subjects and in patients with neurological injury of various kinds (such as multiple sclerosis, Parkinson's disease, dementia, cranial trauma, stroke, epilepsy or other neurological syndromes) as well as to deepen the contribution of specific brain areas in carrying out these cognitive tasks. This will be made possible thanks to the specific skills of a multidisciplinary team of neurologists and physiatrists, health professionals such as physiotherapists, occupational therapists, psychologists, speech therapists, and the support of a biomedical engineer. These professional figures are already available at the UUOOCC of Neurology Neurosurgery and Neurosurgery directed by the proposer.

Conditions

Brain Damage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

Patient with any form ob brain damage

Group Type: EXPERIMENTAL

Cognitive evaluation

Intervention Type: BEHAVIORAL

Cognitive task

Non-invasive brain stimulation

Intervention Type: DEVICE

Transcranial Magnetic Stimulation (TMS)

Control Group

Healthy volounteers

Group Type: OTHER

Cognitive evaluation

Intervention Type: BEHAVIORAL

Cognitive task

Non-invasive brain stimulation

Intervention Type: DEVICE

Transcranial Magnetic Stimulation (TMS)

Interventions

Cognitive evaluation

Cognitive task

Intervention Type: BEHAVIORAL

Non-invasive brain stimulation

Transcranial Magnetic Stimulation (TMS)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Males or females aged between 18 and 80;
• Presence of brain damage resulting from: Multiple Sclerosis, Parkinson Disease, Dementia, Cranial Trauma, Neurosurgical Intervention, Ictus, Epilepsy or Other Neurological Syndromes (for the experimental group only);
• Absence of neurological disorders (for the control group only);
• be able to follow the protocol's directions throughout the study;
• Female subjects undertake not to schedule a pregnancy for the duration of the study;
• Patients should be able to follow protocol guidelines throughout the study;
• Patients should be able to understand the aims and risks of the study;
• Signature of informed consent, approved by our Ethics Committee.

Exclusion Criteria

• Incapability even partial to understand and want;
• Patients with other pathologies which, according to the opinion of the scientific manager, prevent the recruitment;
• When using non-invasive brain stimulation techniques or subjects should not submit any of their own contraindications (for further details, see the "Methods" and "Stimulation Evaluation Questionnaire" attached to this proposal);
• Pregnancy, breastfeeding, and delivery not less than three months before the start of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Neuromed IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Mario Stampanoni Bassi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diego Centonze, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Neuromed

Locations

IRCCS Neuromed

Pozzilli, Isernia, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Diego Centonze, MD

Role: CONTACT

centonze@uniroma2.it

+39 3934444159

Mario Stampanoni Bassi, MD

Role: CONTACT

mario_sb@hotmail.it

+39 3460181370

Facility Contacts

Stefania Passarelli

Role: primary

direzionescientifica@neuromed.it

+39 0865.915217

References

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Reference Type: RESULT

PMID: 10945804 (View on PubMed)

Other Identifiers

Neuromed_Cog

Identifier Type: -

Identifier Source: org_study_id