Status:
UNKNOWN
Applying Non-invasive Brain Stimulation in Alzheimer's Rehabilitation
Lead Sponsor:
Università degli Studi di Trento
Conditions:
Alzheimer Disease
Mild Cognitive Impairment
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
Presently, few studies have evaluated the clinical impact of rTMS in Alzheimer's disease. Though some studies have demonstrated an improvement, there have been conflicting results, as others do not se...
Detailed Description
METHODS AND PROCEDURES The materials and methods of investigation proposed will be the following: * Administration of rTMS in theta burst mode (TBS - intermittent and continuous) * Administration of...
Eligibility Criteria
Inclusion
- General Inclusion Criteria (must be met for both AD and MCI group):
- right-handed
- normal or corrected to normal vision through lenses
- meet inclusion criteria related to TMS
- Be able to provide information regarding their cognitive and functional skills, or have a caregiver available who is able to provide the patient information necessary for participation in the study and who is present when signing the patient's informed consent.
- AD Patient
- Mini Mental State Examination (MMSE) score ≥ 16;
- Stable intake of cholinesterase inhibitors for at least 3 months before the start of the protocol
- MCI Patient
- Diagnosis of mild cognitive impairment
- Mini Mental State Examination (MMSE) score ≥ 24;
- Patients will be selected through clinical evaluation (battery of neuropsychological tests at the Neurocognitive Rehabilitation Center (CeRiN) and, in accordance with the APSS, a CSF and PET examination will be performed as well as a further finalized neuropsychological evaluation for research.
Exclusion
- Patients who are unable to perform the tasks required by the experimental procedure;
- History and / or evidence of any other central nervous system disorder that could be interpreted as a cause of dementia such as structural or developmental abnormality, epilepsy, infectious disease, degenerative or inflammatory/demyelinating diseases of the central nervous system such as Parkinson's disease or Fronto-temporal dementia
- History of significant psychiatric disease which, in the investigator's judgment, could interfere with study participation
- History of alcohol or other substance abuse, according to DSM-V criteria, or recent or previous history of drug abuse if this could be a contributing factor to dementia
- Ongoing treatments with drugs that contain / intake of the following substances: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel dust), gamma-hydroxybutyrate acid (GHB), theophylline
- Presence of cardiac pacemakers, electronic prostheses, bio-stimulators, metal inserts or electrodes implanted in the brain or skull or spine.
- Absolute exclusion criteria (Criteria for TMS), which in detail are:
- presence of cardiac pace-makers, artificial heart valves and / or bio-stimulators
- presence of hearing aids located in the middle ear;
- presence of metal inserts on the head and shoulders;
Key Trial Info
Start Date :
April 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04866979
Start Date
April 6 2021
End Date
January 31 2024
Last Update
May 10 2023
Active Locations (1)
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1
Centro Interdipartimentale Mente/Cervello - CIMeC
Rovereto, Trento, Italy, 38068