Brain DamageCogNCT03344731
Cognitive Abilities in Brain Damaged Patients
A study testing Cognitive evaluation and Non-invasive brain stimulation in people with Brain Damage, run by Neuromed IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Damage
- What is being tested?
- Cognitive evaluation and Non-invasive brain stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2017to 31 Dec 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Neuromed
Pozzilli, Isernia, 86077
Stefania Passarelli, +39 0865.915217, direzionescientifica@neuromed.it
About this study
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).
Read the 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
- Being tested
- Cognitive evaluation, Non-invasive brain stimulation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive evaluationBehavioural
Cognitive task
Non-invasive brain stimulationDevice
Transcranial Magnetic Stimulation (TMS)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patient with any form ob brain damage Receives: Behavioral: Cognitive evaluation; Device: Non-invasive brain stimulation |
| Control Group | Other | Healthy volounteers Receives: Behavioral: Cognitive evaluation; Device: Non-invasive brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start15 Dec 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Brain DamageStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Stampanoni Bassi, Neuromed IRCCS
- Investigators
- Diego Centonze, MD, Principal investigator, IRCCS Neuromed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344731
- Sponsor's protocol ID
- Neuromed_Cog
- Acronym
- Cog
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2017
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9153480Chiaravalloti ND, DeLuca J. Cognitive impairment in multiple sclerosis. Lancet Neurol. 2008 Dec;7(12):1139-51. doi: 10.1016/S1474-4422(08)70259-X.
PubMed 19007738Fortin 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.
PubMed 12784889Jochumsen 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.
PubMed 26648859Rossini 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.
PubMed 25797650Schrag 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.
PubMed 10945804
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Abilities in Brain Damaged Patients
- ClinicalTrials.gov ID
- NCT03344731
- Acronym / sponsor ID
- Cog / Neuromed_Cog
- Conditions
- Brain Damage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Nov 2017 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Cognitive evaluation, Device: Non-invasive brain stimulationPatient with any form ob brain damage |
| Control Group | Other | Behavioral: Cognitive evaluation, Device: Non-invasive brain stimulationHealthy volounteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Cognitive evaluationCognitive task | Behavioural | Control Group, Experimental Group |
| Non-invasive brain stimulationTranscranial Magnetic Stimulation (TMS) | Device | Control Group, Experimental Group |
Primary outcome
Learning
Time frame: up to 3 years
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
Time frame: up to 3 years
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
Time frame: up to 3 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Results publication: PubMed 9153480Chen 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 publication: PubMed 19007738Chiaravalloti 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 publication: PubMed 12784889Fortin 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 publication: PubMed 26648859Jochumsen 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 publication: PubMed 25797650Rossini 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 publication: PubMed 10945804Schrag 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.
- Individual participant dataSharing planned: No
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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.
Diego Centonze, MD principal investigator
IRCCS Neuromed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive evaluation and Non-invasive brain stimulation in people with Brain Damage, run by Neuromed IRCCS 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 8 inclusion and 4 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 31 Oct 2022. 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. 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?
Contact Diego Centonze, MD (+39 3934444159, centonze@uniroma2.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning (time frame: up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03344731, which also lists 6 linked publications.
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 31 Oct 2022.