Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation

NCT01958437 | Completed Results FDA Device

• 1 other identifier: C1381-P
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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.

  Outcome assessed after each of 2 sessions (estimated within 1 week of each other)

• 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.

  change between active and sham tDCS sessions (<1month)

• 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.

  change between active and sham tDCS sessions (<1month)

• Egocentric

  Number of turns correctly recalled for each egocentric environment

  Outcome assessed after each of the 2 sessions

Study Arms (4)

Cognitively intact older adults - ACTIVE tDCS

EXPERIMENTAL

Group receives active brain stimulation

Device: Transcranial direct current stimulation (tDCS)

MCI ACTIVE tDCS

ACTIVE COMPARATOR

Group receives active brain stimulation

Device: Transcranial direct current stimulation (tDCS)

Cognitively intact older adults - SHAM tDCS

SHAM COMPARATOR

Group receives sham brain stimulation

Device: Transcranial direct current stimulation (tDCS)

MCI SHAM tDCS

SHAM COMPARATOR

Group receives sham brain stimulation

Device: Transcranial direct current stimulation (tDCS)

Interventions

Transcranial direct current stimulation (tDCS) DEVICE

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).

Cognitively intact older adults - ACTIVE tDCS; Cognitively intact older adults - SHAM tDCS; MCI ACTIVE tDCS; MCI SHAM tDCS

Eligibility Criteria

• Age: 50 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (2)

• 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.

  PMID: 25647757 RESULT

• 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.

  PMID: 34602464 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Dementia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. Benjamin Hampstead
• Organization: VA Ann Arbor Healthcare System; University of Michigan

bhampste@med.umich.edu

7347639259

Study Officials

• Benjamin M Hampstead, PhD

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Transcranial Direct Current Stimulation

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: October 9, 2013
• Study Start: October 1, 2013
• Primary Completion: March 23, 2017
• Study Completion: March 24, 2017
• Last Updated: August 31, 2018
• Results First Posted: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)