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Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation

Primary Purpose

Mild Cognitive Impairment, Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Aging, Alzheimer's Disease/Dementia, Cognitive Disorders, Imaging, Magnetic Resonance Imaging (MRI), Neurology, Physical Medicine & Rehabilitation, transcranial direct current stimulation

Eligibility Criteria

50 Years - 88 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA
  • VA Ann Arbor Healthcare System, Ann Arbor, MI

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Sham Comparator

Sham Comparator

Arm Label

Cognitively intact older adults - ACTIVE tDCS

MCI ACTIVE tDCS

Cognitively intact older adults - SHAM tDCS

MCI SHAM tDCS

Arm Description

Group receives active brain stimulation

Group receives active brain stimulation

Group receives sham brain stimulation

Group receives sham brain stimulation

Outcomes

Primary Outcome Measures

Accuracy in Centimeters From Target Location for Allocentric
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.
Hippocampal BOLD Signal During Task-based fMRI
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.
Dorsal Attention Network Connectivity During Resting-state fMRI
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.
Egocentric
Number of turns correctly recalled for each egocentric environment

Secondary Outcome Measures

Full Information

First Posted
September 23, 2013
Last Updated
August 28, 2018
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01958437
Brief Title
Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation
Official Title
Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2013 (Actual)
Primary Completion Date
March 23, 2017 (Actual)
Study Completion Date
March 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer's Disease
Keywords
Aging, Alzheimer's Disease/Dementia, Cognitive Disorders, Imaging, Magnetic Resonance Imaging (MRI), Neurology, Physical Medicine & Rehabilitation, transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Transcranial Direct Current Stimulation
Masking
ParticipantInvestigator
Masking Description
Double blinded
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitively intact older adults - ACTIVE tDCS
Arm Type
Experimental
Arm Description
Group receives active brain stimulation
Arm Title
MCI ACTIVE tDCS
Arm Type
Active Comparator
Arm Description
Group receives active brain stimulation
Arm Title
Cognitively intact older adults - SHAM tDCS
Arm Type
Sham Comparator
Arm Description
Group receives sham brain stimulation
Arm Title
MCI SHAM tDCS
Arm Type
Sham Comparator
Arm Description
Group receives sham brain stimulation
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Accuracy in Centimeters From Target Location for Allocentric
Description
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.
Time Frame
Outcome assessed after each of 2 sessions (estimated within 1 week of each other)
Title
Hippocampal BOLD Signal During Task-based fMRI
Description
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.
Time Frame
change between active and sham tDCS sessions (<1month)
Title
Dorsal Attention Network Connectivity During Resting-state fMRI
Description
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.
Time Frame
change between active and sham tDCS sessions (<1month)
Title
Egocentric
Description
Number of turns correctly recalled for each egocentric environment
Time Frame
Outcome assessed after each of the 2 sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin M Hampstead, PhD
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25647757
Citation
England HB, Fyock C, Meredith Gillis M, Hampstead BM. Transcranial direct current stimulation modulates spatial memory in cognitively intact adults. Behav Brain Res. 2015 Apr 15;283:191-5. doi: 10.1016/j.bbr.2015.01.044. Epub 2015 Jan 31.
Results Reference
result
PubMed Identifier
34602464
Citation
Lengu K, Ryan S, Peltier SJ, Tyszkowski T, Kairys A, Giordani B, Hampstead BM. Effects of High Definition-Transcranial Direct Current Stimulation on Local GABA and Glutamate Levels Among Older Adults with and without Mild Cognitive Impairment: An Exploratory Study. J Alzheimers Dis. 2021;84(3):1091-1102. doi: 10.3233/JAD-201091.
Results Reference
derived

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Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation

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