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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014