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CompletedNo phase

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
Record updated
20 March 2025