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NCT05730296
Transcranial Magnetic Stimulation in Patients With Mild Cognitive Impairment - RCT Trial
Conditions: Mild Cognitive Impairment
Sex: All
Ages: 55 Years – 85 Years
Phase: NA
Enrollment: 60
Sponsor: Wroclaw Medical University
Location: Poland
Summary
The study is planned as a randomized, double-blind, and sham-controlled parallel trial, in which raters and participants will be blinded to the group selection.
A total of 60 participants, meeting the eligibility criteria, will be enrolled in the study and divided randomly into 3 groups (2 experimental ones with active rTMS, one of which with the addition of cognitive training RehaCom, one control group with sham-placebo rTMS).
Eligibility Criteria
Detailed inclusion Criteria:participants of both sexes with MCIinformed consent to undergo rTMS and study protocolScreening procedure of cognitive deficits:confirmation of the diagnosis of MCI according to Petersen's criteria (concern related to the change in cognitive performance, deterioration in one or more cognitive areas, maintaining the independent ability of daily functioning, lack of dementia)confirmation of the diagnosis of MCI based on the results obtained in neuropsychological tests (MoCA, Montreal Cognitive Assessment test and CDR, Clinical Dementia Rate)Detailed exclusion criteria (TMS and fMRI)Contraindications to treatments using TMS:positive history of epileptic seizures or a positive family history of epilepsymagnetic or ferromagnetic implants, both electronic (e.g., heart/brain stimulators) as well as mechanical (eg bone anastomoses) within the head and neckprevious stroke or head injury with identified neurological deficitsincreased intracranial pressure or a positive history of increased intracranial pressurepregnant women and women during lactationContraindications to MR examinations:claustrophobiamagnetic or ferromagnetic implants, both electronic (e.g., cardiac/brain stimulators) as well as mechanical (eg bone anastomoses) within the head and neckother psychiatric disorders (i.e.
depression, anxiety disorders), which may affect cognitive performance (GDS-15, 15-Item Geriatric Depression Scale; HAMA-14, 14-Item Hamilton Anxiety Scale)bracesoccurrence of significant pathologies in the cerebrum area (tumors, hydrocephalus, strokes)lack of patient's informed consentdocumented persistent lack of cooperation in treatment
Source: ClinicalTrials.gov (NCT05730296). StuddyBuddy aggregates publicly available trial information.