Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease
This study is currently recruiting participants.
Verified July 2011 by Brainsway
Sponsor:
Brainsway
Information provided by:
Brainsway
ClinicalTrials.gov Identifier:
NCT01179373
First received: August 8, 2010
Last updated: July 4, 2011
Last verified: July 2011
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
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 2012 |
| Estimated Primary Completion Date: | August 2011 (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:
- 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.
Contacts and Locations
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: | Dr. Danicek Veronika, Merhchav Clinics |
| ClinicalTrials.gov Identifier: | NCT01179373 History of Changes |
| Other Study ID Numbers: | 10003 |
| Study First Received: | August 8, 2010 |
| Last Updated: | July 4, 2011 |
| 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 May 19, 2013