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Brain Stimulation and Cognitive Training in Healthy Older Adults (TrainStim)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03838211
Recruitment Status : Active, not recruiting
First Posted : February 12, 2019
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
Technische Universität Dresden
Information provided by (Responsible Party):
University Medicine Greifswald

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.

Condition or disease Intervention/treatment Phase
Aging Device: Anodal tDCS Behavioral: Intensive cognitive training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: tDCS-accompanied Cognitive Training Effects in Healthy Older Adults - Randomised, Sham Controlled, Interventional Study
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : December 1, 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: stimulation group
Anodal tDCS + intensive cognitive Training
Device: Anodal tDCS
Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA)

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

Sham Comparator: sham group
Sham tDCS + intensive cognitive Training
Behavioral: Intensive cognitive training
Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838211


Locations
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Germany
University Medicine Greifswald
Greifswald, Germany, 17475
Sponsors and Collaborators
University Medicine Greifswald
Technische Universität Dresden
Investigators
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Study Director: Agnes Flöel, Prof. University Medicine Greifswald
  Study Documents (Full-Text)

Documents provided by University Medicine Greifswald:
Statistical Analysis Plan  [PDF] January 20, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT03838211    
Other Study ID Numbers: TrainStim3
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Medicine Greifswald:
memory
brain stimulation