Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease (TMS in AD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Brainsway
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00753662
First received: September 14, 2008
Last updated: September 12, 2011
Last verified: September 2011

September 14, 2008
September 12, 2011
November 2008
November 2012   (final data collection date for primary outcome measure)
ADAS-COG [ Time Frame: Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17) ] [ Designated as safety issue: Yes ]
ADAS-COG [ Time Frame: Baseline, 2 months, 4 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00753662 on ClinicalTrials.gov Archive Site
CGI-C, Neuropsychological computerized test (Mindstream),CGI-C,FAB,ADL, Beck Depression Inventory. [ Time Frame: Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17) ] [ Designated as safety issue: Yes ]
CGI-C, Neuropsychological computerized test NexSig [ Time Frame: Baseline, 2 months, 4 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease
Phase 2 (Feasibility) Study of Transcranial Magnetic Stimulation as Additional Therapy to Drug Treatment in Patients With Alzheimer's Disease

The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H2 coil to prefrontal and parieto-temporal cortex 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, Neuropsychological computerized test (Mindstream), FAB,ADL, Beck Depression Inventory-time frame baseline,1 month (visit 12) 2 months (visit 16), 4 months (visit 17).

Estimated enrollment: 45 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2012 Number of arms: 3 Interventions details: H2 coil device for Transcranial Magnetic Stimulation with MAGSTIM to prefrontal and parieto-temporal regions bilaterally with frequency 10Hz in one arm, 1Hz in the second arm, and sham-stimulation with frequency 10Hz/1Hz in third arm.

Ages: 50-80 Genders: both

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Device: 1Hz TMS with H2 coil
    1Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
    Other Name: 1Hz TMS with H2 coil
  • Device: 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
    10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
    Other Name: 10Hz TMS with H2 coil
  • Device: SHAM TMS with H2 coil
    SHAM TMS with H2 coil to prefrontal and parieto-temporal cortex
    Other Name: SHAM TMS with H2 coil
  • Active Comparator: 1
    15 patients in group 1 will be treated with 1Hz frequency
    Intervention: Device: 1Hz TMS with H2 coil
  • Active Comparator: 2
    15 patients in group 2 will be treated with 1Hz frequency 10Hz
    Intervention: Device: 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
  • Sham Comparator: 3
    15 patients in group 3 will be treated with SHAM (1Hz/10Hz)
    Intervention: Device: SHAM TMS with H2 coil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent will be obtained
  • diagnostic evidence of probable AD consistent with DSM IV
  • stable treatment with Acetylcholine-Esterase Inhibitors or/and Memantine for 5 weeks prior to screening
  • stable dose treatment with other drugs
  • MMSE <25

Exclusion Criteria:

  • Patients with neurological or psychiatric disorders that affect cognition but are distinguishable from AD
  • Patients who are unwilling or unable to fulfill the requirements of the study
  • Severe personality disorder
  • Malignant or untreated Hypertension
  • History of Epilepsy
  • History of Head trauma
  • Metal implant in head, cardiac pacemaker, medical pump
  • Drug or alcohol addiction
  • Involvement in any other clinical trial during the preceding 3 month
  • Patient who are unwilling or unable to give Informed Consent
Both
50 Years to 80 Years
No
Contact: Alissa Ash, Dr. +972-3-6973698 elissaa@tasmc.health.gov.il
Israel
 
NCT00753662
TASMC-08-AA-0397-CTIL
Yes
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Brainsway
Principal Investigator: Alissa Ash, Dr. Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
September 2011

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