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Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation

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ClinicalTrials.gov Identifier: NCT01958437
Recruitment Status : Completed
First Posted : October 9, 2013
Results First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief Summary:

Remembering how to travel from one location to another is critical in everyday life, yet this vital ability declines with normal aging and can be further affected by conditions that disproportionately affect the elderly, such as vision loss or progressive dementia. Human and animal research has shown that two distinct memory systems interact during navigation. The first, referred to as allocentric navigation, is very flexible and uses spatial knowledge of key features or landmarks to develop and use a mental map of the environment. This approach involves brain regions that are critical for new learning and memory but that decline with age. The second, referred to as egocentric navigation, is inflexible and relies on "habit" memories that link specific features with specific directions. This approach relies on brain regions that are critical for "automatic" responses and that are relatively unaffected by age.

The main problem is that allocentric navigation declines with age and is accompanied increased dependence on egocentric navigation. This change increases the risk of becoming disoriented or "lost" when traveling in unfamiliar areas or even when traveling new routes in familiar areas. Therefore, the main goal of this project is to examine whether non-invasive brain stimulation, specifically transcranial direct current stimulation, can improve allocentric navigation in healthy older adults and patients with mild cognitive impairment.

Participants will complete two functional magnetic resonance imaging sessions while learning new environments. Before one of these sessions, participants will receive active brain stimulation over the parietal cortex. Before the other session, participants will receive sham brain stimulation over the parietal cortex. The effects of this stimulation will be evaluated using both an allocentric and an egocentric memory test. Physiologic effects will be evaluated using both task-based and resting-state MRI.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer's Disease Device: Transcranial direct current stimulation (tDCS) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Transcranial Direct Current Stimulation
Masking: Double (Participant, Investigator)
Masking Description: Double blinded
Primary Purpose: Treatment
Official Title: Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation
Actual Study Start Date : October 1, 2013
Actual Primary Completion Date : March 23, 2017
Actual Study Completion Date : March 24, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cognitively intact older adults - ACTIVE tDCS
Group receives active brain stimulation
 Device: Transcranial direct current stimulation (tDCS)
Active and/or sham; All participants receive both stimulation condition. Groups will be counterbalanced (half receiving active tDCS in the first session and sham in the second session; the other half receiving the opposite).
Active Comparator: MCI ACTIVE tDCS
Group receives active brain stimulation
 Device: Transcranial direct current stimulation (tDCS)
Active and/or sham; All participants receive both stimulation condition. Groups will be counterbalanced (half receiving active tDCS in the first session and sham in the second session; the other half receiving the opposite).
Sham Comparator: Cognitively intact older adults - SHAM tDCS
Group receives sham brain stimulation
 Device: Transcranial direct current stimulation (tDCS)
Active and/or sham; All participants receive both stimulation condition. Groups will be counterbalanced (half receiving active tDCS in the first session and sham in the second session; the other half receiving the opposite).
Sham Comparator: MCI SHAM tDCS
Group receives sham brain stimulation
 Device: Transcranial direct current stimulation (tDCS)
Active and/or sham; All participants receive both stimulation condition. Groups will be counterbalanced (half receiving active tDCS in the first session and sham in the second session; the other half receiving the opposite).


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy in Centimeters From Target Location for Allocentric [ Time Frame: Outcome assessed after each of 2 sessions (estimated within 1 week of each other) ]
    1 active tDCS; 1 sham tDCS for each measure. Participants touched a screen (using a ELO 19" touchscreen monitor) to document the location of the landmark. The distance between the actual vs. selected location served as the dependent measure.

  2. Hippocampal BOLD Signal During Task-based fMRI [ Time Frame: change between active and sham tDCS sessions (<1month) ]
    BOLD signal change comparing active to sham tDCS during Allocentric navigation (i.e., active HD-tDCS > sham HD-tDCS). Activation maps thresholded at p<.01 with minimum cluster size of 5 voxels.

  3. Dorsal Attention Network Connectivity During Resting-state fMRI [ Time Frame: change between active and sham tDCS sessions (<1month) ]
    Change in resting state functional connectivity strength between active and sham tDCS sessions. Strength is measured by Pearson r correlations between nodes, which are z-transformed, and summated.

  4. Egocentric [ Time Frame: Outcome assessed after each of the 2 sessions ]
    Number of turns correctly recalled for each egocentric environment


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

General inclusion criteria (all participants):

  • All medications stable for approximately 1-2 months;
  • No history of severe mental illness;
  • No current untreated alcohol or substance abuse/dependence;
  • English as native and preferred language;
  • MRI-compatible if taking part in fMRI studies
  • Able to give informed consent.

MCI Inclusion Criteria:

  • Diagnosis of amnestic MCI based on criteria set forth by Petersen (2004). Additionally, other potential causes of cognitive deficit ruled out by the referring physician;

Healthy older adults

  • intact cognitive functioning as measured by neuropsychological testing

Exclusion Criteria:

  • History of neurological disease or injury
  • History of severe mental illness
  • Current untreated alcohol or substance abuse
  • Other conditions may exclude; please discuss with contact
Contacts and Locations
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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): NCT01958437


Locations
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United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Benjamin M Hampstead, PhD VA Ann Arbor Healthcare System, Ann Arbor, MI
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Study Protocol and Statistical Analysis Plan  [PDF] March 20, 2018

More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01958437    
Other Study ID Numbers: C1381-P
First Posted: October 9, 2013    Key Record Dates
Results First Posted: August 31, 2018
Last Update Posted: August 31, 2018
Last Verified: August 2018
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Aging
Alzheimer's Disease/Dementia
Cognitive Disorders
Imaging
 Magnetic Resonance Imaging (MRI)
Neurology
Physical Medicine & Rehabilitation
transcranial direct current stimulation
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders