Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by Brainsway
Sponsor:
Information provided by (Responsible Party):
Brainsway
ClinicalTrials.gov Identifier:
NCT01179373
First received: August 8, 2010
Last updated: June 13, 2013
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Device: TMS, H coil
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Brainsway:

Primary Outcome Measures:
  • cognitive functioning score by ADAS-COG [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Global advancement score by CGI-C [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Frontal lobe functioning score by FAB [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Daily activity score by ADL [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: August 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: TransCranial Magnetic Stimulation

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

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01179373

Locations
Israel
Merchav Clinics Not yet recruiting
Tel Aviv, Israel
Contact: Veronica Danicek, Dr.    035613737    merhav@012.net.il   
Merchav Clinics Recruiting
Tel Aviv, Israel
Contact: Veronica Vachapov, Dr.    035613737      
Contact: hamutal shahar    025824030      
Sponsors and Collaborators
Brainsway
  More Information

No publications provided

Responsible Party: Brainsway
ClinicalTrials.gov Identifier: NCT01179373     History of Changes
Other Study ID Numbers: 10003
Study First Received: August 8, 2010
Last Updated: June 13, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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 July 26, 2014