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Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01958437
First received: September 23, 2013
Last updated: May 26, 2017
Last verified: May 2017
  Purpose

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 Intervention Phase
Mild Cognitive Impairment Alzheimer's Disease Device: Transcranial direct current stimulation (tDCS) Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Behavioral performances (accuracy & reaction time) on experimental stimuli (allocentric and egocentric spatial memory). fMRI correlates of behavioral change. [ Time Frame: Outcome assessed after each of 2 sessions (estimated within 1 week of each other) ]
    1 active tDCS; 1 sham tDCS

  • BOLD signal during task-based fMRI [ Time Frame: change between active and sham tDCS sessions (<1month) ]
  • BOLD signal during resting-state fMRI [ Time Frame: change between active and sham tDCS sessions (<1month) ]

Estimated Enrollment: 40
Actual Study Start Date: October 1, 2013
Estimated Study Completion Date: October 1, 2018
Primary Completion Date: February 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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: Arm 2
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).

  Eligibility

Ages Eligible for Study:   50 Years to 88 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01958437

Locations
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
Principal Investigator: Benjamin M Hampstead, PhD VA Ann Arbor Healthcare System, Ann Arbor, MI
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01958437     History of Changes
Other Study ID Numbers: C1381-P
Study First Received: September 23, 2013
Last Updated: May 26, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No
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:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2017