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Completed

NCT Number: NCT03838211

Brain Stimulation and Cognitive Training in Healthy Older Adults

The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in healthy older individuals.

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Key information

Conditions

Aging

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medicine Greifswald

Greifswald, 17475, Germany

About this study

The goal of the present study is to assess behavioral (primary) and neural 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 aging still need to be elucidated. Healthy older adults will participate in a three-week cognitive training with concurrent online tDCS application. Cognitive performance (primary), as well as structural and functional imaging data 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. Furthermore, to assess neural correlates of performance improvement, functional and structural parameters will be measured with MRI before and after training. Follow-up sessions to assess long-term effects are planned four weeks and six months after the post assessment. The results of the study will offer valuable insights into efficacy of combined tDCS and cognitive training, as compared to training alone, in older adults. Moreover, improved understanding of tDCS effects on cognitive training performance and underlying neural correlates may help to develop novel approaches for cognitive decline in healthy and pathological aging.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Older adults (65 - 80 years);
  • Right handedness;
  • Unobtrusive neuropsychological screening

Exclusion criteria

  • Mild cognitive impairment (MCI) or dementia; other neurodegenerative neurological disorders; epilepsy; 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;
  • Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women)

Treatment and study plan

Anodal tDCS

Device

Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA)

Intensive cognitive training

Behavioral

Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions

Primary outcomes

  1. 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

  1. Working memory training performance (Markov task)

    Time frame: 3 weeks

    Performance in second memory training task (Markov decision making) under anodal tDCS compared to sham condition, analyzed immediately after training period (anodal condition versus sham)

  2. Transfer outcomes

    Time frame: 3 weeks

    Performance in cognitive transfer tasks, comparing performance immediately before and after training period (anodal condition versus sham)

  3. Long-term outcomes

    Time frame: 4 weeks after training, 6 months after 4-week follow-up

    Long-term performance in training and transfer tasks, comparing performance immediately before and after training period with performance at 4 weeks and 6-months after training period (anodal condition versus sham)

  4. Neural correlates

    Time frame: 3 weeks, 6 months

    Structural and functional neural correlates of the intervention, as measured by structural, functional resting-state and diffusion weighted MRI, immediately before and after the intervention and 6 months after follow-up (anodal condition versus sham)

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • Technische Universität Dresden

Registry information

Official study title

tDCS-accompanied Cognitive Training Effects in Healthy Older Adults - Randomised, Sham Controlled, Interventional Study

Acronym: TrainStim

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 12, 2019
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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