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Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT01179373
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Brainsway

August 8, 2010
August 11, 2010
January 25, 2018
August 2010
January 2015   (Final data collection date for primary outcome measure)
cognitive functioning score by ADAS-COG [ Time Frame: 4 months ]
Same as current
Complete list of historical versions of study NCT01179373 on ClinicalTrials.gov Archive Site
  • Global advancement score by CGI-C [ Time Frame: 4 months ]
  • Frontal lobe functioning score by FAB [ Time Frame: 4 months ]
  • Daily activity score by ADL [ Time Frame: 4 months ]
Same as current
Not Provided
Not Provided
 
Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease
Phase 2 Study of Trans Cranial Magnetic Stimulation as Additional Therapy Patients With Alzheimer's Disease
The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training, to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.

Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C,FAB, ADL, Neuropsychological computerized test(time frame baseline, 2 months, 4 months.

Estimated enrollment: 40 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2009 Number of arms: 2

Ages: 50-85 Genders: both

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Alzheimer's Disease
Device: TMS, H coil
TMS, H Coil, High/ Low Frequency
Other Name: TransCranial Magnetic Stimulation
  • Active Comparator: TMS, High Frequency
    High Frequency TMS with H coil to prefrontal cortex
    Intervention: Device: TMS, H coil
  • Active Comparator: TMS, Low Frequency
    Low Frequency TMS to Prefrontal cortex
    Intervention: Device: TMS, H coil
  • Placebo Comparator: Sham Stimulation
    Sham TMS with H Coil on Prefrontal Cortex
    Intervention: Device: TMS, H coil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
Same as current
June 2015
January 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Men and women aged 50-85.
  2. Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria).
  3. Scored below 24 on the MMSE.
  4. Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks, with either no effect or only partial response.
  5. Answered in the negative to all questions in the pre-TMS treatment safety questionnaire.
  6. Gave their oral and written consent to participate in the trial.

Exclusion criteria:

  1. An additional neurological or psychiatric disorder.
  2. Severe personality disorder.
  3. Uncontrolled hypertension.
  4. History of epilepsy, seizure, or heat convulsion.
  5. History of epilepsy or seizure in first degree relatives.
  6. History of head injury or stroke.
  7. History of metal implants in the head (except dental fillings).
  8. 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.
  9. History of migraines in the last six months.
  10. History of drug or alcohol abuse.
  11. Inadequate communication with examiner.
  12. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
  13. Inability to sign a consent form.
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01179373
10003
No
Not Provided
Not Provided
Brainsway
Brainsway
Not Provided
Not Provided
Brainsway
January 2018

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