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

This study is not yet open for participant recruitment.
Verified November 2011 by Brainsway
Sponsor:
Information provided by (Responsible Party):
Brainsway
ClinicalTrials.gov Identifier:
NCT01464515
First received: October 25, 2011
Last updated: November 2, 2011
Last verified: November 2011

October 25, 2011
November 2, 2011
November 2011
November 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01464515 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Mild Cognitive Impairment
  • Device: H-Coil Deep TMS
    this group will receive high frequency treatment of deep TMS with 10Hz
  • Device: SHAM Coil TMS
    this group will receive SHAM treatment of deep TMS
  • Active Comparator: Real TMS
    this group will receive high frequency deep TMS treatment of 10HZ
    Intervention: Device: H-Coil Deep TMS
  • Sham Comparator: SHAM TMS
    this group will receive SHAM treatment of deep TMS
    Intervention: Device: SHAM Coil TMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
55 Years to 80 Years
No
Contact: Ellisa Ash, Dr. +97236973698 elissaa@tasmc.health.gov.il
Israel
 
NCT01464515
P-0021
No
Brainsway
Brainsway
Not Provided
Principal Investigator: Elissa Ash, Dr. Ichilov Hospital
Brainsway
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP