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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01464515
• Other study ID #: P-0021
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 2021
• Est. completion date: January 2021

Study information

• Verified date: January 2020
• Source: Brainsway
• Contact: Ellisa Ash, Dr.
• Phone: +97236973698
• Email: elissaa[@]tasmc.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• H-Coil Deep TMS
this group will receive high frequency treatment of deep TMS with 10Hz
• SHAM Coil TMS
this group will receive SHAM treatment of deep TMS

Locations

Country	Name	City	State
Israel	Ichilov Hospital, Neurological Department	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Brainsway

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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