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NCT02959502Fut, nem toboroz

Home-Based CR and tDCS to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression

Home-Based Cognitive Remediation and Transcranial Direct Current Stimulation to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 13.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

The overall goals of this project are to assess the feasibility and impact of designing and implementing an at-home intervention aimed at preventing long-term cognitive decline and improving cognition in individuals currently at-risk for developing AD.

Állapot (regiszter)
Fut, nem toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
40 (tervezett)
Első benyújtás
2016. nov. 2.
Kezdés
2016. okt. 31.
Elsődleges befejezés
2023. márc. 23.
Fő szponzor
Centre for Addiction and Mental Health
NCT-szám
NCT02959502

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 40
  • 2016. okt. 31. és az elsődleges befejezés (2023. márc. 23.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

A regiszterben nem jelölt feltételek

  • MCI Group
  • Inclusion:
  • Age > 60 (on day of randomization)
  • DSM-IV criteria for Mild Neurocognitive Disorder ("MCI")
  • Willingness to provide informed consent
  • MADRS score of 10 or below
  • Availability of a study partner who has regular contact with the participant
  • Ability to read and communicate in English (with corrected vision and hearing, if needed)
    • Exclusion:
  • Met DSM-IV criteria for Major Depressive Episode in past 10 years
  • Lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or OCD
  • DSM-IV diagnosis of alcohol or other substances use disorder within the past 12 months
  • High risk for suicide
  • Significant neurological condition (e.g., stroke, seizure disorder, MS)
  • Unstable medical illness, (e.g., uncontrolled diabetes mellitus or hypertension)
  • Having taken a cognitive enhancer (acetylcholinesterase inhibitor or memantine) within the past 6 weeks
  • Participants taking anticonvulsants, and other psychotropic medication (see exception below) that cannot be safely tapered and discontinued. The following psychotropic medications are allowed if they have been taken at a stable dose for at least 4 weeks prior to study entry: zopiclone, trazadone, or a benzodiazepine; gabapentin, pregabalin, duloxetine, venlafaxine, or low-dose tricyclic antidepressants if prescribed for chronic pain.
  • A pace-maker or other metal implants that would preclude safe use of tDCS.
    • MDD Group
    • Inclusion:
  • Age ≥ 60 (on day of randomization)
  • Meets DSM-IV criteria for one or more MDE(s)with:
    • an offset of 2 months to 5 years from the screening visit date. It is not necessary for this (these) episode(s) to have received medical attention
    • OR
    • an offset of 5 years or more from the screening visit date. It is necessary that at least one MDE received medical attention (e.g., previously been on one or more antidepressant(s), saw a psychiatrist, primary care physician, or had a previous hospitalization). Also, the MDE must have occurred during the participant's adult life (i.e., at 18 years of age or older).
  • MADRS score of 10 or below
  • Willingness to provide informed consent
  • Availability of a study partner who has regular contact with the participant
  • Ability to read and communicate in English (with corrected vision and hearing, if needed)
    • Exclusion:
  • Meets DSM-IV criteria for Major Neurocognitive Disorder ("dementia")
  • Lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or OCD
  • DSM-IV diagnosis of alcohol or other substances use disorder within the past 12 months.
  • High risk for suicide.
  • Significant neurological condition (e.g., stroke, seizure disorder, MS)
  • Unstable medical illness (e.g., uncontrolled diabetes mellitus or hypertension)
  • Participants taking anticonvulsants, and other psychotropic medication (see exception below) that cannot be safely tapered and discontinued. In addition to any antidepressant, the following psychotropic medications are allowed if they have been taken at a stable dose for at least 4 weeks prior to study entry: zopiclone, trazodone, or a benzodiazepine; and gabapentin or pregabalin if prescribed for chronic pain.
  • Having taken a cognitive enhancer (acetylcholinesterase inhibitor or memantine) within the past 6 weeks.
  • A pace-maker or other metal implants that would preclude safe use of tDCS.
    • Facilitator Group
    • Inclusion:
  • Willingness to provide informed consent
  • Ability to read and communicate in English (with corrected vision and hearing, if needed)
    • Exclusion:
  • Physical or medical illness that prevents participant from learning or administering CR + tDCS, as determined by the research team

Életkor a regiszterben: 60 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Centre for Addiction and Mental HealthTorontoKanadaIsmeretlen állapot

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