Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease

January 24, 2018 updated by: Brainsway

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

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 Locations

  • Israel
      • Tel Aviv, Israel
        • Merchav Clinics

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 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TMS, High Frequency
High Frequency TMS with H coil to prefrontal cortex
Device: TMS, H coil
TMS, H Coil, High/ Low Frequency
Other Names:
  • TransCranial Magnetic Stimulation
ACTIVE_COMPARATOR: TMS, Low Frequency
Low Frequency TMS to Prefrontal cortex
Device: TMS, H coil
TMS, H Coil, High/ Low Frequency
Other Names:
  • TransCranial Magnetic Stimulation
PLACEBO_COMPARATOR: Sham Stimulation
Sham TMS with H Coil on Prefrontal Cortex
Device: TMS, H coil
TMS, H Coil, High/ Low Frequency
Other Names:
  • TransCranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cognitive functioning score by ADAS-COG
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Global advancement score by CGI-C
Time Frame: 4 months
4 months
Frontal lobe functioning score by FAB
Time Frame: 4 months
4 months
Daily activity score by ADL
Time Frame: 4 months
4 months

Collaborators and Investigators

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

Sponsor

Brainsway

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 (ACTUAL)

August 1, 2010

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

August 8, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (ESTIMATE)

August 11, 2010

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10003

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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