Transcranial Direct Current Stimulation for Depression in Alzheimer's Disease Patient - Preliminary Research
NCT ID: NCT02351388
Last Updated: 2020-02-26
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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TERMINATED
NA
4 participants
INTERVENTIONAL
2014-12-31
2018-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active stimulation
Duration: 30 minutes Intensity: 2 mA Placement: left dorsolateral prefrontal cortex and right supraorbital area Size of electrodes: 5 cm x 7 cm Frequency: 5 days a week for three weeks
Transcranial Direct Current Stimulation
Sham stimulation
Duration: 30 minutes Intensity: 2 mA Placement: left dorsolateral prefrontal cortex and right supraorbital area Size of electrodes: 5 cm x 7 cm Frequency: 5 days a week for three weeks
Sham Stimulation
Interventions
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Transcranial Direct Current Stimulation
Sham Stimulation
Eligibility Criteria
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Inclusion Criteria
2. Participants who meets criteria of depression in Alzheimers defined by NIMH criteria.
3. Participants who have been on fixed dose (including participants without any prescription) of antidepressants for at least two weeks on the screening visit.
4. Participants who have been on fixed dose (including participants not prescribed) of antidementia drugs (donepezil, rivastigmine, galantamine, and memantine) for at least for weeks on the screening visit.
5. Ambulatory participants with or without any aiding device
6. Participants who have one caregiver, who must live with the patient at least ten hours a week and must report the patient's behavior.
7. A study partner who can report how the participant is doing is needed.
8. Eligible family member must sign and give consent on behalf of participants, whereas participants can give assent.
Exclusion Criteria
2. In case they have history of epilepsy
3. In case they need treatment by antipsychotics due to significant psychotic symptoms
4. In case they have urgent risk of suicide or severe depression and any doctor require their hospitalization to psychiatric units.
5. In case they have history of ineffectiveness with electroconvulsive therapy (ECT) or transcranial direct current stimulation (tDCS)
6. In case ECT or tDCS is clinically contraindicated
7. In case they are taking benzodiazepines or antiepileptic drugs on the screening visit
8. In case they scored less than ten on Mini Mental State Exam (MMSE) or scored 3 or more on Clinical Dementia Rating (CDR)
9. In case his/her GDS score is lower than 6 at baseline
10. In case he/she is unable to agree video recording on evaluation interview
65 Years
90 Years
ALL
No
Sponsors
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National Center of Neurology and Psychiatry, Japan
OTHER
Responsible Party
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Principal Investigators
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Yuma Yokoi, MD
Role: PRINCIPAL_INVESTIGATOR
National Center of Neurology and Psychiatry, Japan
Locations
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National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan
Countries
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References
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Narita Z, Yokoi Y. Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial. Trials. 2017 Jun 19;18(1):285. doi: 10.1186/s13063-017-2019-z.
Related Links
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Other Identifiers
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A2014-086
Identifier Type: -
Identifier Source: org_study_id
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