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

Brainsway

Status and phase: Unknown; Phase 1

Conditions: Mild Cognitive Impairment

Treatments: Device: H-Coil Deep TMS; Device: SHAM Coil TMS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01464515

P-0021

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Real TMS

Active Comparator group

Description:

this group will receive high frequency deep TMS treatment of 10HZ

Treatment:

Device: H-Coil Deep TMS

SHAM TMS

Sham Comparator group

Description:

this group will receive SHAM treatment of deep TMS

Treatment:

Device: SHAM Coil TMS