Cognitive Abilities in Brain Damaged Patients

NCT03344731 | Unknown

• 1 other identifier: Neuromed_Cog
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Brain Damage

Outcome Measures

Primary Outcomes (3)

• 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).

  up to 3 years

• 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.

  up to 3 years

• 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.

  up to 3 years

Study Arms (2)

Experimental Group

EXPERIMENTAL

Patient with any form ob brain damage

Behavioral: Cognitive evaluation; Device: Non-invasive brain stimulation

Control Group

OTHER

Healthy volounteers

Behavioral: Cognitive evaluation; Device: Non-invasive brain stimulation

Interventions

Cognitive evaluation BEHAVIORAL

Cognitive task

Control Group; Experimental Group

Non-invasive brain stimulation DEVICE

Transcranial Magnetic Stimulation (TMS)

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

IRCCS Neuromed

Pozzilli, Isernia, 86077, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 9153480 RESULT

• 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.

  PMID: 19007738 RESULT

• 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.

  PMID: 12784889 RESULT

• 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.

  PMID: 26648859 RESULT

• 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.

  PMID: 25797650 RESULT

• 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.

  PMID: 10945804 RESULT

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Diego Centonze, MD

  IRCCS Neuromed

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Centonze, MD

CONTACT

+39 3934444159; centonze@uniroma2.it

Mario Stampanoni Bassi, MD

CONTACT

+39 3460181370; mario_sb@hotmail.it

Study Design

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

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 17, 2017
• Study Start: December 15, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)