- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03441152
The Effects of Transcranial Direct Current Stimulation in Mild Cognitive Impairment
The Neural Effects of Multisession Transcranial Direct Current Stimulation in Older Adults at Risk for Mild Cognitive Impairment and Its Impact in Cognitive Functions and Everyday Memory: A Randomized Controlled Trial
Objectives: 1) To examine whether the real transcranial direct current stimulation (tDCS) group would perform better in the cognitive training (CT) intervention than the sham tDCS group and the CT group; 2) To determine if, as a consequence of the stimulation generated by the use of tDCS, there would be a transfer effect to other cognitive domains and to cognitive tasks in activities of daily living; 3) To investigate the time and spatial responses of tDCS on the brain cortex during and after tDCS application.
Hypothesis to be tested: By applying anodal tDCS with the combination of a CT delivered via the use of tablet PCs in older adults at risk of MCI, it will enhance their cognitive task performance in CT and subsequently generalize to other cognitive domains as well, involving a transferability to cognitive tasks in activities of daily living.
Design and subjects: A multi-centered single-blinded randomized controlled trial (RCT) with three groups (CT alone/Sham tDCS with the combination of a CT/ Real tDCS coupling with CT) The participants who will take part of this study will be older adults at risk of MCI Study instruments: tDCS, Ipad, Neuron Up CT Apps, EEG. Interventions: The intervention will last for 9 sessions (3 sessions per week for 3 weeks). Sham tDCS and real tDCS, will be combined with the same CT which is used in the CT group. During the experimental intervention, anodal tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and cathodal tDCS on the contralateral deltoid muscle with the combination of a CT. During the experimental intervention, anodal tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and cathodal tDCS on the contralateral deltoid muscle with the combination of a CT.
Main outcome measures: Cognitive assessments, CT performance, EEG. In addition, delta and theta frequency suppression and alpha increment power under the anode electrode will be observed.
Studieöversikt
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Pablo Cruz Gonzalez
- Telefonnummer: +852 62382024
- E-post: pablo.cruzgonzalez@connect.polyu.hk
Studera Kontakt Backup
- Namn: Kenneth Fong
- Telefonnummer: +852 2766 6716
- E-post: rsnkfong@polyu.edu.hk
Studieorter
-
-
-
Hong Kong, Hong Kong, Hung Hom
- Rekrytering
- The Hong Kong Polytechnic University
-
Kontakt:
- Pablo Cruz Gonzalez
- Telefonnummer: +85262382024
- E-post: pablo.cruzgonzalez@connect.polyu.hk
-
Kontakt:
- Kenneth Fong
- Telefonnummer: +85227666716
- E-post: rsnkfong@polyu.edu.hk
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
The inclusion criteria will follow the modified Petersen's criteria:
- Aged between 60 and 85 years old;
- Obtaining a score on the Montreal Cognitive Assessment Test (MoCA) between 19 and 26;
- Achieving a score on the Clinical Dementia Rating (CDR) of 0.5 or below ;
- Self-reported cognitive decline by the participants themselves and
Being independent in daily living activities.
Additional criteria in this study include:
- Having completed three or more years of primary education;
- Ability to participate in a therapy session lasting at least 30 minutes;
- Community ambulant with or without aids; and
- Ability to perform a proper range of motion with hands in order to use a tablet PC.
Exclusion Criteria:
- 1) Individuals presenting with a diagnosis of dementia or any other neurological disease; (2) Individuals with depression determined by a score on Geriatric Depression Scale of >5, (3) History of drug or alcohol abuse or dependence in the last 3 months; and (4) Participants who had metallic fixtures around the cephalic area or skin lesions in the areas at where the electrodes were going to be attached were excluded from the study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: tDCS+CT
application of tDCS in combination with CT
|
Transkraniell likströmsstimulering
|
Sham Comparator: Sham tDCS
application of sham tDCS in combination with CT
|
Transkraniell likströmsstimulering
|
Aktiv komparator: CT
application of CT
|
Transkraniell likströmsstimulering
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Montreal Cognitive Assessment (MoCA)
Tidsram: 10 minutes
|
It is a 30-point test about several cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation) and a screening tool used of MCI and dementia.
|
10 minutes
|
Digit Span Test
Tidsram: 10 minutes
|
The test measures short term memory in such a way that sequences of digits are presented and have to be recalled in forward and reverse order.
Testing ends when the maximal list length is reached or when subjects fail to recall the trial at one sequence length.
|
10 minutes
|
Trial Making Test (TMT)
Tidsram: 5 minutes
|
TMT encompasses visual attention and processing speed, it consists of 2 parts in which a set of 25 dots in the first part and 24 dots in the second part have to be accurately connected.
Time performance is measured as the main outcome
|
5 minutes
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Riverhead Behavioral Memory Test (3rd edition) (RBMT-3)
Tidsram: 40 minutes
|
It includes 14 subtests assessing aspects of visual, verbal, recall, recognition, immediate and delayed everyday memory.
Additionally prospective memory skills and the ability to learn new information are measured as well
|
40 minutes
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Cognitive training activities ( Neuronup cognitive training)
Tidsram: 30 minutes each session ( 9 sessions in total)
|
Performance of the cognitive training activities conducted every session
|
30 minutes each session ( 9 sessions in total)
|
EEG
Tidsram: 15 minutes
|
time and spatial responses of tDCS on the brain cortex before and after tDCS application
|
15 minutes
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HongKongPUPabloRS
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Lätt kognitiv funktionsnedsättning
-
University of Texas Southwestern Medical CenterTEXAS ALZHEIMER'S RESEARCH & CARE CONSORTIUMRekryteringDemens | Lätt kognitiv funktionsnedsättning | Amnestic Mild Cognitive Impairment - aMCIFörenta staterna
-
Johns Hopkins UniversityNational Institute on Aging (NIA)RekryteringSömnstörning | AMCI - Amnestic Mild Cognitive ImpairmentFörenta staterna
-
Dart NeuroScience, LLCAvslutadAge-Associated Memory Impairment (AAMI)Förenta staterna
-
Invendo Medical GmbHAvslutad
-
St. Boniface HospitalPizzey Ingredients; Canadian Agricultural PartnershipAktiv, inte rekryterandeMinne; Störning, mildKanada
-
Mayo ClinicRekryteringAutonom kortisolutsöndring | Mild autonom kortisolsekretion (MACS)Förenta staterna
-
Chonbuk National University HospitalAvslutadMild leverskadaKorea, Republiken av
-
Abramson Cancer Center of the University of PennsylvaniaIndragenAllvarlig eller mild toxicitet från strålbehandling och/eller kemoterapiFörenta staterna
-
Solta MedicalAvslutadMild till måttlig akneFörenta staterna
-
ValbiotisUniversity Hospital, Clermont-Ferrand; Clinic'n'CellRekryteringNAFLD | MASLD | Mild inflammatorisk kontextFrankrike
Kliniska prövningar på tDCS
-
Hôpital le VinatierAvslutadSchizofreni | Auditiva hallucinationerFrankrike, Tunisien
-
Universidad de AlmeriaSecretaría General de Universidades, Investigación y Tecnología, Junta...Anmälan via inbjudanSubstansrelaterade störningarSpanien
-
Northeastern UniversityMassachusetts General Hospital; National Institute on Aging (NIA)Okänd
-
University of ArizonaRekrytering
-
Bambino Gesù Hospital and Research InstituteAvslutad
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)AvslutadMotorisk aktivitet | Motorisk neuroplasticitetFörenta staterna
-
Charite University, Berlin, GermanyAvslutadMigrän Med Aura | CADASIL | Cerebral mikroangiopati | ICA StenosTyskland
-
Universidade Federal de PernambucoAvslutad
-
New York UniversityRekryteringFriskaFörenta staterna
-
Thorsten RudroffAvslutadMultipel skleros | Neuropatisk smärtaFörenta staterna