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

Phase 1

• Conditions: Mild Cognitive Impairment
• Interventions: Device: SHAM Coil TMS; Device: H-Coil Deep TMS

• Registration Number: NCT01464515
• Lead Sponsor: Brainsway

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-03
• Status Verified: 2020-01
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14
• Study Start: 2021-01
• Primary Completion: 2021-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHAM TMS	SHAM Coil TMS	this group will receive SHAM treatment of deep TMS
Real TMS	H-Coil Deep TMS	this group will receive high frequency deep TMS treatment of 10HZ

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ichilov Hospital, Neurological Department; 🇮🇱 Tel Aviv, Israel