Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease

This study is currently recruiting participants.

Verified July 2011 by Brainsway

Sponsor:

Information provided by:

Brainsway

ClinicalTrials.gov Identifier:

NCT01179373

First received: August 8, 2010

Last updated: July 4, 2011

Last verified: July 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 8, 2010
Last Updated Date	July 4, 2011
Start Date ^ICMJE	August 2010
Estimated Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 10, 2010)	cognitive functioning score by ADAS-COG [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01179373 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 10, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease
Official Title ^ICMJE	Phase 2 Study of Trans Cranial Magnetic Stimulation as Additional Therapy Patients With Alzheimer's Disease
Brief Summary	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.
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 ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Condition ^ICMJE	Alzheimer's Disease
Intervention ^ICMJE	Device: TMS, H coil TMS, H Coil, High/ Low Frequency Other Name: TransCranial Magnetic Stimulation
Study Arm (s)	Active Comparator: TMS, High Frequency High Frequency TMS with H coil to prefrontal cortex Intervention: Device: TMS, H coil Active Comparator: TMS, Low Frequency Low Frequency TMS to Prefrontal cortex Intervention: Device: TMS, H coil Placebo Comparator: Sham Stimulation Sham TMS with H Coil on Prefrontal Cortex Intervention: Device: TMS, H coil
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	45
Estimated Completion Date	August 2012
Estimated Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Men and women aged 50-85. Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria). Scored below 24 on the MMSE. 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. Answered in the negative to all questions in the pre-TMS treatment safety questionnaire. Gave their oral and written consent to participate in the trial. Exclusion criteria: An additional neurological or psychiatric disorder. Severe personality disorder. Uncontrolled hypertension. History of epilepsy, seizure, or heat convulsion. History of epilepsy or seizure in first degree relatives. History of head injury or stroke. History of metal implants in the head (except dental fillings). 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. History of migraines in the last six months. History of drug or alcohol abuse. Inadequate communication with examiner. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it. Inability to sign a consent form.
Gender	Both
Ages	50 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01179373
Other Study ID Numbers ^ICMJE	10003
Has Data Monitoring Committee	No
Responsible Party	Dr. Danicek Veronika, Merhchav Clinics
Study Sponsor ^ICMJE	Brainsway
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Brainsway
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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