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

This study is currently recruiting participants.
Verified September 2011 by Tel-Aviv Sourasky Medical Center
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
 Device: 1Hz TMS with H2 coil
Device: 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
Device: SHAM TMS with H2 coil
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 (Feasibility) Study of Transcranial Magnetic Stimulation as Additional Therapy to Drug Treatment in Patients With Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • ADAS-COG [ Time Frame: Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: November 2008
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
15 patients in group 1 will be treated with 1Hz frequency
 Device: 1Hz TMS with H2 coil
1Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
Other Name: 1Hz TMS with H2 coil
Active Comparator: 2
15 patients in group 2 will be treated with 1Hz frequency 10Hz
 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
Sham Comparator: 3
15 patients in group 3 will be treated with SHAM (1Hz/10Hz)
 Device: SHAM TMS with H2 coil
SHAM TMS with H2 coil to prefrontal and parieto-temporal cortex
Other Name: SHAM TMS with H2 coil

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753662

Contacts
Contact: Alissa Ash, Dr. +972-3-6973698 elissaa@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center, Neurology Department Recruiting
Tel Aviv, Israel, 64239
Contact: Alissa Ash, Dr.     972-3-6973698     elissaa@tasmc.health.gov.il    
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Brainsway
Investigators
Principal Investigator: Alissa Ash, Dr. Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Michal Roll PhD,MBA, Dr. Alissa Ash, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00753662     History of Changes
Other Study ID Numbers: TASMC-08-AA-0397-CTIL
Study First Received: September 14, 2008
Last Updated: September 12, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
TMS AD H2 coil

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013