Mild Cognitive Impairment
Conditions
Keywords
Mild Cognitive Impairment, So Stated, Deep Transcranial Magnetic Stimulation
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 impairment). The hypothesis of the study is that high frequency treatment with deep TMS will improve the daily functioning of patients who suffers from MCI.
Interventions
DEVICEH-Coil Deep TMS
this group will receive high frequency treatment of deep TMS with 10Hz
DEVICESHAM Coil TMS
this group will receive SHAM treatment of deep TMS
Sponsors
Brainsway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women 50-80 years of age. 2. Self reporting of the patient about memory deterioration, without any damage of daily lify functioning. 3. 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) 4. score \>= 24 in MMSE (Mini Mental State Examination) test. 5. Preserved Cognitive and executive functioning, without dementia according to DSM -IV 6. Lack of other reason for memory deterioration like acute affect disorder or other neurological disorders, according to the doctor diagnosis. 7. 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. 8. Capable and willing to provide informed consent.
Exclusion criteria
1. Any other Axis I diagnosis as the primary diagnosis 2. Any medications that can cause a risk of seizure. for instance, anti psychotic medication, high dosage of anti depression medication 3. History of non tolerance for TMS treatment 4. Diagnosis of Severe personality disorder according to DSM-IV 5. current suicidal tendency 6. Uncontrolled hypertension 7. History of epilepsy, seizure, or heat convulsion 8. History of epilepsy or seizure in first degree relatives 9. History of head injury or stroke 10. History of metal implants in the head (except dental fillings) 11. 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 12. History of drug or alcohol abuse 13. Inadequate communication with examiner 14. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it 15. Inability to sign a consent form 16. Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mindstreams | the test will be assessed on visit 17 which means 4 month from baseline | Mindstreams test is designed to test the I.Q change of the patients from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CDR - Clinical Dementia Rating | the test will be assessed on visit 17 which means 4 month from baseline | CDR test is designed to test the dementia severity of the patients from baseline |
Countries
Israel
Contacts
Primary ContactEllisa Ash, Dr.
Outcome results
None listed