Investigating cognitive abilities in patients with brain damage
Cognitive Abilities in Brain Damaged Patients
This study is testing how brain damage affects thinking skills in people with conditions like multiple sclerosis, Parkinson's disease, and dementia, while also trying out brain stimulation techniques to see if they can help improve those skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Neuromed IRCCS Academic / other |
| Locations | 1 site (Pozzilli, Isernia) |
| Trial ID | NCT03344731 on ClinicalTrials.gov |
What this trial studies
This study aims to assess cognitive abilities in patients suffering from various forms of brain damage, including conditions like multiple sclerosis, Parkinson's disease, and dementia. Participants will undergo a series of cognitive tests and questionnaires to evaluate functions such as decision-making, memory, and social cognition. Additionally, the study will utilize non-invasive brain stimulation techniques, including Transcranial Magnetic Stimulation (TMS) and Direct Transcranial Electric Stimulation (tDCS), to modulate brain activity and understand the contribution of specific brain areas to cognitive tasks.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 18 to 80 with brain damage from conditions like multiple sclerosis, Parkinson's disease, or dementia.
Not a fit: Patients with neurological disorders who do not have brain damage or those unable to follow the study protocol may not benefit.
Why it matters
Potential benefit: If successful, this study could enhance understanding of cognitive deficits in brain-damaged patients and lead to improved therapeutic strategies.
How similar studies have performed: Other studies utilizing non-invasive brain stimulation techniques have shown promise in improving cognitive functions, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pozzilli, Isernia
- IRCCS Neuromed — Pozzilli, Isernia, Italy (Recruiting)
Study contacts
- Principal investigator: Diego Centonze, MD — IRCCS Neuromed
- Study coordinator: Diego Centonze, MD
- Email: centonze@uniroma2.it
- Phone: +39 3934444159
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.