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

This study is currently recruiting participants.
Verified November 2011 by Brainsway
Sponsor:
Information provided by (Responsible Party):
Brainsway
ClinicalTrials.gov Identifier:
NCT01464515
First received: October 25, 2011
Last updated: May 30, 2013
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Mild Cognitive Impairment
Device: H-Coil Deep TMS
Device: SHAM Coil TMS
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Feasibility Study in Order to Test the Efficiency of Deep TMS on Patient With MCI

Resource links provided by NLM:


Further study details as provided by Brainsway:

Primary Outcome Measures:
  • Mindstreams [ Time Frame: the test will be assessed on visit 17 which means 4 month from baseline ] [ Designated as safety issue: No ]
    Mindstreams test is designed to test the I.Q change of the patients from baseline


Secondary Outcome Measures:
  • CDR - Clinical Dementia Rating [ Time Frame: the test will be assessed on visit 17 which means 4 month from baseline ] [ Designated as safety issue: No ]
    CDR test is designed to test the dementia severity of the patients from baseline


Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464515

Contacts
Contact: Ellisa Ash, Dr. +97236973698 elissaa@tasmc.health.gov.il

Locations
Israel
Ichilov Hospital, Neurological Department Recruiting
Tel Aviv, Israel
Contact: Elissa Ash, Dr.    +97236973698    elissaa@tasmc.health.gov.il   
Sponsors and Collaborators
Brainsway
Investigators
Principal Investigator: Elissa Ash, Dr. Ichilov Hospital
  More Information

No publications provided

Responsible Party: Brainsway
ClinicalTrials.gov Identifier: NCT01464515     History of Changes
Other Study ID Numbers: P-0021
Study First Received: October 25, 2011
Last Updated: May 30, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Brainsway:
Mild Cognitive Impairment, So Stated
Deep Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014