TMS Treatment of Social Cognition Skills in Mild Cognitive Impairment
Key facts
- Who runs it
- Ospedale Regionale di Lugano
- Where
- Switzerland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 28 people enrolled
- Started
- 11 Feb 2021
- Ended
- 31 Mar 2024
- Type of study
- Interventional, 2 groups
- Treatments tested
- rTMS treatment
- Record updated
- 20 March 2025
Who can take part
- Age
- 50 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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
- Any uncontrolled medical or neurological/neurodegenerative condition (other than MCI)
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 impairments in theory of mind (ToM) and facial emotion recognition. Moreover, in amnesic MCI patients, reduced ToM ability appears to be correlated with worse performances at several cognitive performances. These findings, in agreement with previous evidence, confirm that impaired social cognition might occur prior to dementia: typically elderly start to show impairment in the complex ToM levels, which is found also in MCI patients and proceeds further in AD patients. Thus, the treatment of these aspects has the potential to influence the trajectory of neurodegeneration. In the last decade, it has been increasingly evident the effectiveness of active stimulation of brain regions with repetitive transcranial magnetic stimulation (rTMS), to improve cognitive and functional performances in patients with dementia.
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On the other hand, brain imaging techniques and TMS stimulations have identified two main areas responsible for human social cognition- the medial prefrontal cortex (MPFC) and the right temporo-parietal junction (RTPJ).
In this project, we hypothesized that an improvement of social cognition skills may be obtained in MCI patients by using the rTMS on two main areas responsible for human social cognition- the medial prefrontal cortex (MPFC) and the right temporoparietal junction (RTPJ). Moreover, it expects that rTMS treatment may also contribute to improving cognitive abilities and neuropsychiatric aspects partially modulated by the same networks stimulated.
The 2 groups in the trial
- RR-GRTreatment being tested
MCI patients with social cognition deficits will receive 4 weeks of rTMS stimulation
Treatment: rTMS treatment
- SR-GROther group
MCI patients with social cognition deficits will receive 2 weeks of placebo treatment, followed by 2 weeks of real rTMS stimulation
Treatment: rTMS treatment
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- EFFECTS OF rTMS TREATMENT ON SOCIAL COGNITION DYSFUNCTIONS IN MILD COGNITIVE IMPAIRMENT: AN PROSPECTIVE, DOUBLE-BINDING, RANDOMIZED, SINGLE CENTRE, EXPLORATIVE STUDY
- Publications
- Enhancing Social Cognition in Mild Cognitive Impairment with Non-Invasive Brain Stimulation: A Randomized Clinical Trial.Neurorehabilitation and neural repair, 2025
- Record updated
- 20 March 2025