Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation

NCT ID: NCT01958437

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-01
• Study Completion Date: 2017-03-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cognitively intact older adults - ACTIVE tDCS

Group receives active brain stimulation

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (tDCS)

Intervention Type: 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).

MCI ACTIVE tDCS

Group receives active brain stimulation

Group Type: ACTIVE_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type: 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 - SHAM tDCS

Group receives sham brain stimulation

Group Type: SHAM_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type: 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).

MCI SHAM tDCS

Group receives sham brain stimulation

Group Type: SHAM_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin M Hampstead, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System, Ann Arbor, MI

Locations

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25647757 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34602464 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

C1381-P

Identifier Type: -

Identifier Source: org_study_id