Neurostimulation and Cognitive Intervention in Alzheimer's Disease
NCT ID: NCT02772185
Last Updated: 2016-05-13
Study Results
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Basic Information
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UNKNOWN
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2016-05-31
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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active tDCS plus real CT
Participants will receive active transcranial direct current stimulation and real cognitive training.
active tDCS
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
real CT
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).
sham tDCS plus real CT
Participants will receive sham transcranial direct current stimulation and real cognitive training.
sham tDCS
The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham.
real CT
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).
active tDCS plus placebo CT
Participants will receive active transcranial direct current stimulation and placebo cognitive training.
active tDCS
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
placebo CT
Videos (short films) will be presented during the neurostimulation
sham tDCS plus placebo CT
Participants will receive sham transcranial direct current stimulation and placebo cognitive training.
sham tDCS
The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham.
placebo CT
Videos (short films) will be presented during the neurostimulation
Interventions
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active tDCS
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
sham tDCS
The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham.
real CT
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).
placebo CT
Videos (short films) will be presented during the neurostimulation
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with Alzheimer's Disease, according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) and NINCDS-ADRDA (National Institute for Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association) criteria
* Score between 18 and 26 on the Mini Mental State Examination
* Have a CDR (Clinical Dementia Rating) of 1.0
* If medicated for AD, then use of cholinesterase inhibitors, for at least 3 months and on stable dose for at least 60 days prior to screening.
Exclusion Criteria
* Other neurologic or psychiatric diagnoses
* Transcranial direct current stimulation criteria: patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy; any other condition that might limit or interfere in the sensorimotor system
60 Years
90 Years
ALL
No
Sponsors
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Federal University of Paraíba
OTHER
Responsible Party
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Suellen Marinho Andrade
Professor
Locations
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Suellen Andrade
João Pessoa, Paraíba, Brazil
Countries
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Central Contacts
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Facility Contacts
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Suellen Andrade
Role: primary
Role: backup
References
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Andrade SM, da Silva-Sauer L, de Carvalho CD, de Araujo ELM, Lima EO, Fernandes FML, Moreira KLAF, Camilo ME, Andrade LMMDS, Borges DT, da Silva Filho EM, Lindquist AR, Pegado R, Morya E, Yamauti SY, Alves NT, Fernandez-Calvo B, de Souza Neto JMR. Identifying biomarkers for tDCS treatment response in Alzheimer's disease patients: a machine learning approach using resting-state EEG classification. Front Hum Neurosci. 2023 Oct 4;17:1234168. doi: 10.3389/fnhum.2023.1234168. eCollection 2023.
Marchi LZ, Ferreira RGD, de Lima GNS, da Silva JAS, da Cruz DMC, Fernandez-Calvo B, Andrade SMMDS. Multisite transcranial direct current stimulation associated with cognitive training in episodic memory and executive functions in individuals with Alzheimer's disease: a case report. J Med Case Rep. 2021 Apr 22;15(1):185. doi: 10.1186/s13256-021-02800-x.
Andrade SM, de Oliveira EA, Alves NT, Dos Santos ACG, de Mendonca CTPL, Sampaio DDA, da Silva EEQC, da Fonseca EKG, de Almeida Rodrigues ET, de Lima GNS, Carvalho J, da Silva JAS, Toledo M, da Rosa MRD, Gomes MQC, de Oliveira MM, Lemos MTM, Lima NG, Inacio P, da Cruz Ribeiro E Rodrigues PM, Ferreira RGD, Cavalcante R, de Brito Aranha REL, Neves R, da Costa E Souza RM, Portugal TM, Martins WKN, Pontes V, de Paiva Fernandes TM, Contador I, Fernandez-Calvo B. Neurostimulation Combined With Cognitive Intervention in Alzheimer's Disease (NeuroAD): Study Protocol of Double-Blind, Randomized, Factorial Clinical Trial. Front Aging Neurosci. 2018 Nov 2;10:334. doi: 10.3389/fnagi.2018.00334. eCollection 2018.
Other Identifiers
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NeuroAD
Identifier Type: -
Identifier Source: org_study_id
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