Efficiency of Deep Transcranial Magnetic Stimulation on Patients With Mild Cognitive Impairment

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility Study in Order to Test the Efficiency of Deep TMS on Patient With MCI

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Device: H-Coil Deep TMS
* Device: SHAM Coil TMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real TMS<br>this group will receive high frequency deep TMS treatment of 10HZ | Device: H-Coil Deep TMS<br>* this group will receive high frequency treatment of deep TMS with 10Hz<br>|
| Sham Comparator: SHAM TMS<br>this group will receive SHAM treatment of deep TMS | Device: SHAM Coil TMS<br>* this group will receive SHAM treatment of deep TMS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mindstreams | Mindstreams test is designed to test the I.Q change of the patients from baseline | the test will be assessed on visit 17 which means 4 month from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CDR - Clinical Dementia Rating | CDR test is designed to test the dementia severity of the patients from baseline | the test will be assessed on visit 17 which means 4 month from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Cognitive Impairment, So Stated, Deep Transcranial Magnetic Stimulation