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

Primary Purpose

Mild Cognitive Impairment

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

H-Coil Deep TMS

SHAM Coil TMS

About this trial

This is an interventional other trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, So Stated, Deep Transcranial Magnetic Stimulation

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women 50-80 years of age.
Self reporting of the patient about memory deterioration, without any damage of daily lify functioning.
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)
score >= 24 in MMSE (Mini Mental State Examination) test.
Preserved Cognitive and executive functioning, without dementia according to DSM -IV
Lack of other reason for memory deterioration like acute affect disorder or other neurological disorders, according to the doctor diagnosis.
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.
Capable and willing to provide informed consent.

Exclusion Criteria:

Any other Axis I diagnosis as the primary diagnosis
Any medications that can cause a risk of seizure. for instance, anti psychotic medication, high dosage of anti depression medication
History of non tolerance for TMS treatment
Diagnosis of Severe personality disorder according to DSM-IV
current suicidal tendency
Uncontrolled hypertension
History of epilepsy, seizure, or heat convulsion
History of epilepsy or seizure in first degree relatives
History of head injury or stroke
History of metal implants in the head (except dental fillings)
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
History of drug or alcohol abuse
Inadequate communication with examiner
Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it
Inability to sign a consent form
Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse

Sites / Locations

Ichilov Hospital, Neurological Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real TMS

SHAM TMS

Arm Description

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

this group will receive SHAM treatment of deep TMS

Outcomes

Primary Outcome Measures

Mindstreams

Mindstreams test is designed to test the I.Q change of the patients from baseline

Secondary Outcome Measures

CDR - Clinical Dementia Rating

CDR test is designed to test the dementia severity of the patients from baseline

Full Information

NCT ID

NCT01464515

First Posted

October 25, 2011

Last Updated

July 13, 2020

Sponsor

Brainsway

1. Study Identification

Unique Protocol Identification Number

NCT01464515

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 2021 (Anticipated)

Primary Completion Date

January 2021 (Anticipated)

Study Completion Date

January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Brainsway

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment, So Stated, Deep Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Real TMS

Arm Type

Active Comparator

Arm Description

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

Arm Title

SHAM TMS

Arm Type

Sham Comparator

Arm Description

this group will receive SHAM treatment of deep TMS

Intervention Type

Device

Intervention Name(s)

H-Coil Deep TMS

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

SHAM Coil TMS

Intervention Description

this group will receive SHAM treatment of deep TMS

Primary Outcome Measure Information:

Title

Mindstreams

Description

Mindstreams test is designed to test the I.Q change of the patients from baseline

Time Frame

the test will be assessed on visit 17 which means 4 month from baseline

Secondary Outcome Measure Information:

Title

CDR - Clinical Dementia Rating

Description

CDR test is designed to test the dementia severity of the patients from baseline

Time Frame

the test will be assessed on visit 17 which means 4 month from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women 50-80 years of age. Self reporting of the patient about memory deterioration, without any damage of daily lify functioning. 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) score >= 24 in MMSE (Mini Mental State Examination) test. Preserved Cognitive and executive functioning, without dementia according to DSM -IV Lack of other reason for memory deterioration like acute affect disorder or other neurological disorders, according to the doctor diagnosis. 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. Capable and willing to provide informed consent. Exclusion Criteria: Any other Axis I diagnosis as the primary diagnosis Any medications that can cause a risk of seizure. for instance, anti psychotic medication, high dosage of anti depression medication History of non tolerance for TMS treatment Diagnosis of Severe personality disorder according to DSM-IV current suicidal tendency Uncontrolled hypertension History of epilepsy, seizure, or heat convulsion History of epilepsy or seizure in first degree relatives History of head injury or stroke History of metal implants in the head (except dental fillings) 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 History of drug or alcohol abuse Inadequate communication with examiner Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it Inability to sign a consent form Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ellisa Ash, Dr.

Phone

+97236973698

elissaa@tasmc.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elissa Ash, Dr.

Organizational Affiliation

Ichilov Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ichilov Hospital, Neurological Department

City

Tel Aviv

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elissa Ash, Dr.

Phone

+97236973698

elissaa@tasmc.health.gov.il

12. IPD Sharing Statement

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

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