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

September 12, 2011 updated by: Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center, Neurology Department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ADAS-COG
Time Frame: Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)
Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Collaborators

Brainsway

Investigators

  • Principal Investigator: Alissa Ash, Dr., Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

September 14, 2008

First Submitted That Met QC Criteria

September 15, 2008

First Posted (Estimate)

September 16, 2008

Study Record Updates

Last Update Posted (Estimate)

September 13, 2011

Last Update Submitted That Met QC Criteria

September 12, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-08-AA-0397-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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