Status:
COMPLETED
TMS Treatment of Social Cognition Skills in Mild Cognitive Impairment
Lead Sponsor:
Ospedale Regionale di Lugano
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
Social cognitive abilities are impaired in around 17% of subjects with mild cognitive impairment (MCI), and might not reflect upon functional status. Compared to healthy controls, MCI showed impairmen...
Detailed Description
This is a prospective, double-binding, cross-sectional, randomized, sham-controlled, and single-center project aimed to investigate the effect of rTMS treatment of social cognition abilities in MCI su...
Eligibility Criteria
Inclusion
- Subjects aged 50 to 85 years old, inclusive, at the time of informed consent;
- Must have at least 5 years of education or work experience to exclude mental deficits other than MCI;
- Must meet Petersen's criteria for mild cognitive impairment, and must have:
- Clinical dementia rating global score of 0.5;
- Mini-Mental State Examination score between 24 and 30;
- Must have a score ≥ 26.5 at Token test to ensure that subjects have the ability to understand the instructions and procedures;
- Must have a score \< 29 at Beck Depression Inventory to exclude major depression that could compromise the patient's ability to engage in the study;
- Apart from a clinical diagnosis of MCI, the subject must be in good health;
- Must be on stable dose of antidepressant (if applicable) for at least 2 months prior to the enrolment.
Exclusion
- Any uncontrolled medical or neurological/neurodegenerative condition (other than MCI);
- Clinical significant unstable psychiatric illness requiring treatment with neuroleptic;
- Transient ischemic attack, stroke, or any unexplained loss of consciousness or severe ongoing stressor within 1 year prior to screening;
- History of seizure within10 years prior to screening;
- Recent history of alcohol or substance abuse or use of cannabinoids;
- Any other medical conditions that are not stable or controlled, or could affect the subject's safety or interfere with the study assessments and treatment;
- Contraindication to having TMS treatment;
- Inability to understand the purpose of the study or to comply with study requirements.
Key Trial Info
Start Date :
February 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04490616
Start Date
February 11 2021
End Date
March 31 2024
Last Update
March 20 2025
Active Locations (1)
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1
Neurocentro della Svizzera italiana,Ospedale Regionale di Lugano
Lugano, Canton Ticino, Switzerland, 6903