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Cognitive Abilities in Brain Damaged Patients (Cog)

Primary Purpose

Brain Damage

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cognitive evaluation
Non-invasive brain stimulation
Sponsored by
Neuromed IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Brain Damage

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • IRCCS NeuromedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental Group

Control Group

Arm Description

Patient with any form ob brain damage

Healthy volounteers

Outcomes

Primary Outcome Measures

Learning
Associative learning tasks will be inspired by those previously used in literature during which subjects should learn a series of stimulus-outcome associations (pavlovian learning) or response-outcome (instrumental learning).
Risk decision-making
Neurological deficits can affect the ability to learn from past mistakes and make decisions for the future. To observe the decision-making mechanisms and to analyze the ability to choose, a series of more or less risky economic choices will be presented, which can result in both a payout or a loss. Initially participants receive a sum of virtual money with the instruction to maximize the payout. An unaltered decision skill should have the ability to make the least risky choice and involve more long-term wins.
Social and emotional cognition
To evaluate social and emotional cognition, a series of tests will be used to quantify both the ability to empathize and understand the emotions of others, and the ability to intrepret their thoughts and intentions. A classical test involves the presentation of facial expressions and is asked to choose which word best describes what the person in the image is thinking or trying.

Secondary Outcome Measures

Full Information

First Posted
October 20, 2017
Last Updated
October 27, 2022
Sponsor
Neuromed IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT03344731
Brief Title
Cognitive Abilities in Brain Damaged Patients
Acronym
Cog
Official Title
Cognitive Abilities in Brain Damaged Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Neuromed IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Damage

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Patient with any form ob brain damage
Arm Title
Control Group
Arm Type
Other
Arm Description
Healthy volounteers
Intervention Type
Behavioral
Intervention Name(s)
Cognitive evaluation
Intervention Description
Cognitive task
Intervention Type
Device
Intervention Name(s)
Non-invasive brain stimulation
Intervention Description
Transcranial Magnetic Stimulation (TMS)
Primary Outcome Measure Information:
Title
Learning
Description
Associative learning tasks will be inspired by those previously used in literature during which subjects should learn a series of stimulus-outcome associations (pavlovian learning) or response-outcome (instrumental learning).
Time Frame
up to 3 years
Title
Risk decision-making
Description
Neurological deficits can affect the ability to learn from past mistakes and make decisions for the future. To observe the decision-making mechanisms and to analyze the ability to choose, a series of more or less risky economic choices will be presented, which can result in both a payout or a loss. Initially participants receive a sum of virtual money with the instruction to maximize the payout. An unaltered decision skill should have the ability to make the least risky choice and involve more long-term wins.
Time Frame
up to 3 years
Title
Social and emotional cognition
Description
To evaluate social and emotional cognition, a series of tests will be used to quantify both the ability to empathize and understand the emotions of others, and the ability to intrepret their thoughts and intentions. A classical test involves the presentation of facial expressions and is asked to choose which word best describes what the person in the image is thinking or trying.
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diego Centonze, MD
Phone
+39 3934444159
Email
centonze@uniroma2.it
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Stampanoni Bassi, MD
Phone
+39 3460181370
Email
mario_sb@hotmail.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diego Centonze, MD
Organizational Affiliation
IRCCS Neuromed
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Neuromed
City
Pozzilli
State/Province
Isernia
ZIP/Postal Code
86077
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefania Passarelli
Phone
+39 0865.915217
Email
direzionescientifica@neuromed.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9153480
Citation
Chen R, Classen J, Gerloff C, Celnik P, Wassermann EM, Hallett M, Cohen LG. Depression of motor cortex excitability by low-frequency transcranial magnetic stimulation. Neurology. 1997 May;48(5):1398-403. doi: 10.1212/wnl.48.5.1398.
Results Reference
result
PubMed Identifier
19007738
Citation
Chiaravalloti ND, DeLuca J. Cognitive impairment in multiple sclerosis. Lancet Neurol. 2008 Dec;7(12):1139-51. doi: 10.1016/S1474-4422(08)70259-X.
Results Reference
result
PubMed Identifier
12784889
Citation
Fortin S, Godbout L, Braun CM. Cognitive structure of executive deficits in frontally lesioned head trauma patients performing activities of daily living. Cortex. 2003 Apr;39(2):273-91. doi: 10.1016/s0010-9452(08)70109-6.
Results Reference
result
PubMed Identifier
26648859
Citation
Jochumsen M, Signal N, Nedergaard RW, Taylor D, Haavik H, Niazi IK. Induction of Long-term Depression-like Plasticity by Pairings of Motor Imagination and Peripheral Electrical Stimulation. Front Hum Neurosci. 2015 Dec 1;9:644. doi: 10.3389/fnhum.2015.00644. eCollection 2015.
Results Reference
result
PubMed Identifier
25797650
Citation
Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10.
Results Reference
result
PubMed Identifier
10945804
Citation
Schrag A, Jahanshahi M, Quinn N. What contributes to quality of life in patients with Parkinson's disease? J Neurol Neurosurg Psychiatry. 2000 Sep;69(3):308-12. doi: 10.1136/jnnp.69.3.308.
Results Reference
result

Learn more about this trial

Cognitive Abilities in Brain Damaged Patients

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