Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease
NCT ID: NCT01885806
Last Updated: 2013-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2013-06-30
2015-12-31
Brief Summary
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Detailed Description
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Eligibility criteria:
* Diagnosis of Alzheimer's disease, mild and moderate stage (MMSE range from 10 to 20);
* Diagnosis of apathy;
* age between 60 and 85 years-old;
* On stable doses of cholinesterase inhibitors (donepezil, rivastigmine, galantamine) or memantine for at least 6 months prior to enrollment;
The primary outcome measures is the Apathy Inventoire. Secondary outcome measures are the NPI score, ADAS-cog scores and the Zarit Burden Scale scores.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Repetitive TMS
Patients will receive 10 consecutive sessions of repetitive transcranial magnetic stimulation with the following protocol:
Frequency: 10 Hz Intensity: 90% motor limiar Session duration: 16 minutes (20 sequencies of 6 seconds of stimulation followed by intervals of 30 seconds); Localization: Left pre-frontal dorsolateral cortex;
Magnetic Stimulator Magstim Rapid 2
All procedures will use the Magnetic Stimulator Magstim Rapid 2. Total of session: 10 rTMS protocol: Freqüency: 10 Hz Intensity: 90% limiar motor Session duration: 16 minutes (20 TMS sequences of 6 second with intervals of 30 seconds between each sequence) Location: Left dorsolateral pre-frontal cortex
Sham TMS
Patients will receive 10 consecutive sessions of sham transcranial magnetic stimulation following the same protocol as the intervention arm, but with no magnetic stimulation of the brain.
Sham Magnetic Stimulator
This intervention will follow the same protocol of the rTMS except that subjects will not receive magnetic stimulation of the brain.
Total of session: 10
Interventions
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Magnetic Stimulator Magstim Rapid 2
All procedures will use the Magnetic Stimulator Magstim Rapid 2. Total of session: 10 rTMS protocol: Freqüency: 10 Hz Intensity: 90% limiar motor Session duration: 16 minutes (20 TMS sequences of 6 second with intervals of 30 seconds between each sequence) Location: Left dorsolateral pre-frontal cortex
Sham Magnetic Stimulator
This intervention will follow the same protocol of the rTMS except that subjects will not receive magnetic stimulation of the brain.
Total of session: 10
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mild or moderate Alzheimer's disease (MMSE scores between 10 and 20)
* Apathy diagnosis
* On stable doses of cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and/or memantine for at least 6 months prior to enrollment
Exclusion Criteria
* History of migraine or headaches episodes twice per week or more
* History of neurodegenerative diseases other than Alzheimer's disease
* Current use of first generation antipsychotics, clozapine, tricyclic drugs or anticonvulsants
* History of cerebral ischemic episode
60 Years
85 Years
ALL
No
Sponsors
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Federal University of Minas Gerais
OTHER
Responsible Party
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Breno Satler de Oliveira Diniz
Assistant Professor
Principal Investigators
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Breno S Diniz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Minas Gerais
Locations
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Federal University of Minas Gerais
Belo Horizonte, Outside of U.S., Brazil
Federal University of Minas Gerais
Belo Horizonte, Outside of U.S., Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CAAE: 15388913.6.0000.5149
Identifier Type: -
Identifier Source: org_study_id
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