Status:
COMPLETED
Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease
Lead Sponsor:
Brainsway
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
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 ...
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. Es...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01179373
Start Date
August 1 2010
End Date
June 1 2015
Last Update
January 25 2018
Active Locations (1)
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1
Merchav Clinics
Tel Aviv, Israel