Clinical trial NCT03838211: Brain Stimulation and Cognitive Training in Healthy Older Adults
Official title: tDCS-accompanied Cognitive Training Effects in Healthy Older Adults - Randomised, Sham Controlled, Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: memory
brain stimulation
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Technische Universität Dresden
First posted: 2019-02-12
Enrollment: 56
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 healthy older individuals.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Working memory training performance (Letter Updating task)
timeFrame: 3 weeks
Secondary outcomes:
measure: Working memory training performance (Markov task)
timeFrame: 3 weeks
measure: Transfer outcomes
timeFrame: 3 weeks
measure: Long-term outcomes
timeFrame: 4 weeks after training, 6 months after 4-week follow-up
measure: Neural correlates
timeFrame: 3 weeks, 6 months
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
Study officials:
affiliation: University Medicine Greifswald
name: Agnes Flöel, Prof.
role: STUDY_DIRECTOR
References:
citation: Antonenko D, Thams F, Uhrich J, Dix A, Thurm F, Li SC, Grittner U, Floel A. Effects of a Multi-Session Cognitive Training Combined With Brain Stimulation (TrainStim-Cog) on Age-Associated Cognitive Decline - Study Protocol for a Randomized Controlled Phase IIb (Monocenter) Trial. Front Aging Neurosci. 2019 Aug 16;11:200. doi: 10.3389/fnagi.2019.00200. eCollection 2019.