Brain Stimulation and Cognitive Training in Healthy Older Adults

NCT ID: NCT03838211

Last Updated: 2021-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-03-25

Brief Summary

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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

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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.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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stimulation group

Anodal tDCS + intensive cognitive Training

Group Type EXPERIMENTAL

Anodal tDCS

Intervention Type DEVICE

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

Intensive cognitive training

Intervention Type BEHAVIORAL

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

sham group

Sham tDCS + intensive cognitive Training

Group Type SHAM_COMPARATOR

Intensive cognitive training

Intervention Type BEHAVIORAL

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

Interventions

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Anodal tDCS

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

Intervention Type DEVICE

Intensive cognitive training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role collaborator

University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Agnes Flöel, Prof.

Role: STUDY_DIRECTOR

University Medicine Greifswald

Locations

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University Medicine Greifswald

Greifswald, , Germany

Site Status

Countries

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Germany

References

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Thams F, Li SC, Floel A, Antonenko D. Functional Connectivity and Microstructural Network Correlates of Interindividual Variability in Distinct Executive Functions of Healthy Older Adults. Neuroscience. 2023 Aug 21;526:61-73. doi: 10.1016/j.neuroscience.2023.06.005. Epub 2023 Jun 14.

Reference Type DERIVED
PMID: 37321368 (View on PubMed)

Antonenko D, Fromm AE, Thams F, Grittner U, Meinzer M, Floel A. Microstructural and functional plasticity following repeated brain stimulation during cognitive training in older adults. Nat Commun. 2023 Jun 2;14(1):3184. doi: 10.1038/s41467-023-38910-x.

Reference Type DERIVED
PMID: 37268628 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31474848 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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TrainStim3

Identifier Type: -

Identifier Source: org_study_id

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