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Neuromodulation of Cognition in Older Adults

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ClinicalTrials.gov Identifier: NCT02137122
Recruitment Status : Recruiting
First Posted : May 13, 2014
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Florida

Brief Summary:
This study will investigate whether transcranial direct current stimulation enhances the effects of cognitive training in healthy older adults.

Condition or disease Intervention/treatment Phase
Healthy Device: Sham Stimulation Device: Transcranial Direct Current Stimulation Not Applicable

Detailed Description:
The current study will investigate methods for enhancing cognitive training effects in healthy older adults by employing a combination of interventions facilitating neural plasticity and optimizing readiness for learning. Adults over the age of 65 represent the fastest growing group in the US population. As such, age-related cognitive decline represents a major concern for public health. Recent research suggests that cognitive training in older adults can improve cognitive performance, with effects lasting up to 10 years. However, these effects are typically limited to the tasks trained, with little transfer to other cognitive abilities or everyday skills. An adaptive pilot randomized clinical trial will examine the individual and combined impact of pairing cognitive training with transcranial direct current stimulation (tDCS). tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions involved in active cognitive function and enhances neural plasticity when paired with a training task. We will compare changes in cognitive and brain function resulting from CT and CT combined with tDCS using a comprehensive neurocognitive, clinical, and multimodal neuroimaging assessment of brain structure, function, and metabolic state.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuromodulation of Cognition in Older Adults: The Stimulated Brain Study
Study Start Date : January 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: Cognitive Training
Participants will undergo 60 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The training control will be the same tasks set at an easy difficulty setting. The group will undergo either transcranial direct current stimulation or sham stimulation.
Device: Sham Stimulation
Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
Other Name: Soterix 1x1 DC stimulator

Device: Transcranial Direct Current Stimulation
Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.
Other Name: Soterix 1x1

Placebo Comparator: Training Control
Participants will undergo 60 hours of training control. Training control will involve the same computerized games as in the cognitive training condition but are set at an easy difficulty setting. The group will undergo either transcranial direct current stimulation or sham stimulation.
Device: Sham Stimulation
Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
Other Name: Soterix 1x1 DC stimulator

Device: Transcranial Direct Current Stimulation
Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.
Other Name: Soterix 1x1




Primary Outcome Measures :
  1. Change in NIH Toolbox Cognitive Composite Score [ Time Frame: 1 year ]
    The NIH Toolbox is a battery of neurocognitive tests created by the National Institute on Aging as a comprehensive measure of cognitive function. We will use the change from baseline to 1 year in the NIH Toolbox Cognitive Composite Score to assess outcome.



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Ages Eligible for Study:   65 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women;
  • Age: 65 to 95 years
  • English speaking
  • Physically mobile

Exclusion Criteria:

  • Neurological disorders
  • Evidence of dementia (MMSE < 20)
  • Past opportunistic brain infection
  • Major psychiatric illness
  • Unstable and chronic (e.g, severe diabetes) medical conditions.
  • MRI contraindications (e.g., pregnancy, claustrophobia, metal implants).
  • Physical impairment precluding motor response or lying still for 1 hr
  • inability to walk two blocks without stopping.

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): NCT02137122


Contacts
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Contact: Adam J Woods, PhD 352-294-5842 ajwoods@ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Adam J Woods, PhD    352-294-5842    ajwoods@ufl.edu   
Principal Investigator: Adam J Woods, PhD         
McKnight Brain Institute Not yet recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Adam J Woods, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02137122     History of Changes
Other Study ID Numbers: IRB201400328-N
1KL2TR001429-01 ( U.S. NIH Grant/Contract )
1K01AG050707-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

Keywords provided by University of Florida:
Volunteers