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Clinical Trials/NCT04265378
NCT04265378
Completed
N/A

Effects of Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease - Randomised, Sham Controlled, Interventional Study

University Medicine Greifswald1 site in 1 country46 target enrollmentMay 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Subjective Cognitive Decline
Sponsor
University Medicine Greifswald
Enrollment
46
Locations
1
Primary Endpoint
Working memory training performance (Letter Updating task)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in individuals with prodromal Alzheimer's disease.

Detailed Description

The goal of the present study is to assess behavioral (primary) effects of a multi-session cognitive training combined with transcranial direct current stimulation (tDCS). Many studies to date have found tDCS to be an efficient method to enhance various cognitive functions by modulating cortical excitability in young adults, but its behavioral impact and underlying mechanisms in pathological aging still need to be elucidated. Individuals with prodromal Alzheimer's disease, will participate in a three-week cognitive training with concurrent online tDCS application. Cognitive performance (primary) will be examined before, during and after the intervention, in order to draw conclusions about the effect of tDCS. In addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. Follow-up sessions to assess long-term effects are planned four weeks and seven months after the post assessment. Furthermore, to assess potential predictors of tDCS effects, functional and structural parameters will be measured with MRI. The results of the study will offer valuable insights into efficacy of combined tDCS and cognitive training, as compared to training alone, in individuals with prodromal stages of Alzheimer's disease. Moreover, improved understanding of tDCS effects on cognitive training performance and underlying neural correlates may help to develop novel approaches for modulating cognitive decline in healthy and pathological aging.

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
October 10, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Medicine Greifswald
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Older adults (60 - 80 years);
  • Right handedness;
  • subjective cognitive decline (SCD) or mild cognitive impairment (MCI)

Exclusion Criteria

  • Dementia or other neurodegenerative neurological disorders; epilepsy or history of seizures; close relatives with epilepsy or history of seizures; previous stroke;
  • Severe and untreated medical conditions that precludes participation in the training, as determined by responsible physician;
  • History of severe alcoholism or use of drugs;
  • Severe psychiatric disorders such as depression (if not in remission) or psychosis

Outcomes

Primary Outcomes

Working memory training performance (Letter Updating task)

Time Frame: 3 weeks

Performance in a memory training task (Letter updating) under anodal tDCS compared to sham condition; operationalized by working Memory Updating performance assessed with number of correctly recalled letter lists in the letter updating task, analyzed immediately after training period (anodal condition versus sham)

Secondary Outcomes

  • Transfer outcomes: Wiener Matrices Test (no. correct)(3 weeks)
  • Long-term outcomes: Markov decision making task (% optimal actions)(4 weeks and 7 months after training)
  • Neural correlates: Structural neural correlates of tDCS effect(before training; 7 months after training)
  • Neural correlates: Functional neural correlates of tDCS effect(before training; 7 months after training)
  • Long-term outcomes: numerical n-back task (% correct)(4 weeks and 7 months after training)
  • Transfer outcomes: AVLT (auditory verbal learning test) (sum of correctly recalled items trials 1-5)(3 weeks)
  • Long-term outcomes: Wiener Matrices Test (no. correct)(4 weeks and 7 months after training)
  • Transfer outcomes: numerical n-back task (% correct)(3 weeks)
  • Long-term outcomes: Letter Updating task (no. of correctly recalled lists)(4 weeks and 7 months after training)
  • Working memory training performance (Markov task)(3 weeks)
  • Long-term outcomes: AVLT (auditory verbal learning test) (sum of correctly recalled items trials 1-5)(4 weeks and 7 months after training)

Study Sites (1)

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