A Phase 2/3 interventional study of active tDCS and sham tDCS in Alzheimer's Disease, sponsored by Federal University of Paraíba. Status unknown at 1 site in Brazil. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-05-13.
Sponsored by Federal University of Paraíba · Phase 2/3, Interventional, and Treatment
This study is a double blind, sham-controlled clinical trial aiming to compare the long-term effects of stimulation in Alzheimer's Disease (AD). Sixty early AD patients will take part in a phase II/III clinical study over a 1-year period. The study involves transcranial direct current stimulation (tDCS), cognitive training (CT), detailed neuropsychological and neurological testing. These assessments will occur at baseline, then again at two month (end point). Those who achieve clinical improvement with neurostimulation and cognitive therapy will be invited to receive treatment for 12 months as part of a follow-up study.
The patients will be randomized into 1 of 4 groups: active tDCS plus real CT, active tDCS plus placebo CT, sham tDCS plus real CT, sham tDCS plus placebo CT. Each group will receive treatment for 30 minutes a day, 3 days a week for 8 weeks.
3,766 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's planned enrollment of 60 is below the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Federal University of Paraíba is the lead sponsor of 73 studies on the registry; 6 are open to participants now.
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Participants will receive active transcranial direct current stimulation and real cognitive training.
Device: active tDCS · Behavioral: real CT
Participants will receive sham transcranial direct current stimulation and real cognitive training.
Device: sham tDCS · Behavioral: real CT
Participants will receive active transcranial direct current stimulation and placebo cognitive training.
Device: active tDCS · Behavioral: placebo CT
Participants will receive sham transcranial direct current stimulation and placebo cognitive training.
Device: sham tDCS · Behavioral: placebo CT
Duration: 30 minutes; Intensity: 2 mA; Placement:left and right parietal cortex, left and right DLPFC, left inferior frontal gyrus and left superior temporal gyrus
The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham.
Cognitive tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left inferior frontal gyrus and left superior temporal gyrus).
Videos (short films) will be presented during the neurostimulation
Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in visuo-spatial working memory assessed on the Corsi block task
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in verbal working memory assessed on the Digit Span task
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in speed of cognitive processing and executive functioning assessed on the Trail Making Test
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in executive function assessed on the Stroop Color and Word Test
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in verbal fluency assessed on the FAS Verbal Fluency Test
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in functional ability assessed on the Disability Assessment Dementia
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in visual recognition assessed on the Poppelreuter-Ghent's Overlapping Figures test
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in behavioral and psychological disturbances assessed on the Neuropsychiatric Inventory Questionnaire
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in subjective burden among caregivers assessed on the Zarit Burden Interview
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Change in electrical activity of the brain assessed on the Electroencephalogram (EEG)
Time frame: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
Side Effects Questionnaire
Time frame: From date of first neurostimulation until the date of last neurostimulation, assessed up to 12 months
The record gives a start of May 2016, a primary completion of May 2018 and a completion of May 2019. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Federal University of Paraíba