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

NCT ID: NCT01464515

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2021-01-31

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Real TMS

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

Group Type: ACTIVE_COMPARATOR

H-Coil Deep TMS

Intervention Type: DEVICE

this group will receive high frequency treatment of deep TMS with 10Hz

SHAM TMS

this group will receive SHAM treatment of deep TMS

Group Type: SHAM_COMPARATOR

SHAM Coil TMS

Intervention Type: DEVICE

this group will receive SHAM treatment of deep TMS

Interventions

H-Coil Deep TMS

this group will receive high frequency treatment of deep TMS with 10Hz

Intervention Type: DEVICE

SHAM Coil TMS

this group will receive SHAM treatment of deep TMS

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brainsway

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elissa Ash, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ichilov Hospital

Locations

Ichilov Hospital, Neurological Department

Tel Aviv, , Israel

Countries

Israel

Central Contacts

Ellisa Ash, Dr.

Role: CONTACT

elissaa@tasmc.health.gov.il

+97236973698

Facility Contacts

Elissa Ash, Dr.

Role: primary

elissaa@tasmc.health.gov.il

+97236973698

Other Identifiers

P-0021

Identifier Type: -

Identifier Source: org_study_id