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

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

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.

Study Overview

• Status: Unknown
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Device: H-Coil Deep TMS; Device: SHAM Coil TMS

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Ichilov Hospital, Neurological Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brainsway
• Investigators: Principal Investigator: Elissa Ash, Dr., Ichilov Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: October 25, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimate): November 3, 2011

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Deep Transcranial Magnetic Stimulation; Mild Cognitive Impairment, So Stated
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: P-0021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No