Status:
UNKNOWN
Efficiency of Deep Transcranial Magnetic Stimulation on Patients With Mild Cognitive Impairment
Lead Sponsor:
Brainsway
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
55-80 years
Phase:
PHASE1
Brief Summary
This is a first feasibility study in order to test if deep Transcranial Magnetic Stimulation (TMS) treatment with high frequency (10Hz) will improve the symptoms of patient MCI (Mild Cognitive impairm...
Eligibility Criteria
Inclusion
- Men and women 50-80 years of age.
- Self reporting of the patient about memory deterioration, without any damage of daily lify functioning.
- Scored of one standard deviation below the average (according to standardization of age and years of schooling) in the memory index and Mindstream test, without any major damage of other cognitive function)
- score \>= 24 in MMSE (Mini Mental State Examination) test.
- Preserved Cognitive and executive functioning, without dementia according to DSM -IV
- Lack of other reason for memory deterioration like acute affect disorder or other neurological disorders, according to the doctor diagnosis.
- Score of maximum 0.5 in the Clinical Dementia Rating. in this test the score of the memory index will be 0.5 or 1, and not more then 1 point in two other index of this test.
- Capable and willing to provide informed consent.
Exclusion
- Any other Axis I diagnosis as the primary diagnosis
- Any medications that can cause a risk of seizure. for instance, anti psychotic medication, high dosage of anti depression medication
- History of non tolerance for TMS treatment
- Diagnosis of Severe personality disorder according to DSM-IV
- current suicidal tendency
- Uncontrolled hypertension
- History of epilepsy, seizure, or heat convulsion
- History of epilepsy or seizure in first degree relatives
- History of head injury or stroke
- History of metal implants in the head (except dental fillings)
- History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neurostimulators, or any medical pumps
- History of drug or alcohol abuse
- Inadequate communication with examiner
- Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it
- Inability to sign a consent form
- Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01464515
Start Date
January 1 2021
End Date
January 1 2021
Last Update
July 14 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ichilov Hospital, Neurological Department
Tel Aviv, Israel