Mild Cognitive ImpairmentNCT01958437

Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation

A study testing Transcranial direct current stimulation (tDCS) in people with Mild Cognitive Impairment and Alzheimer's Disease, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 88 yearsHealthy volunteers can take part
Conditions the study is for: Mild Cognitive Impairment, Alzheimer's Disease
What is being tested?: Transcranial direct current stimulation (tDCS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 2 sitesUnited States
Study dates: 1 Oct 2013to 24 Mar 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 88 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 11Show fewer

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033

Other trials in United States

About this study

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
Being tested: Transcranial direct current stimulation (tDCS)
Keywords: Aging, Alzheimer's Disease/Dementia, Cognitive Disorders, Imaging, Magnetic Resonance Imaging (MRI), Neurology, Physical Medicine & Rehabilitation, transcranial direct current stimulation
Medical subject headings: Cognitive Dysfunction, Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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).

Study groups in NCT01958437
Study group	Role	What they receive
Cognitively intact older adults - ACTIVE tDCS	Experimental	Group receives active brain stimulation Receives: Device: Transcranial direct current stimulation (tDCS)
MCI ACTIVE tDCS	Active comparator	Group receives active brain stimulation Receives: Device: Transcranial direct current stimulation (tDCS)
Cognitively intact older adults - SHAM tDCS	Sham comparator	Group receives sham brain stimulation Receives: Device: Transcranial direct current stimulation (tDCS)
MCI SHAM tDCS	Sham comparator	Group receives sham brain stimulation Receives: Device: Transcranial direct current stimulation (tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: change between active and sham tDCS sessions (<1month)
Egocentric
Number of turns correctly recalled for each egocentric environment
Measured: Outcome assessed after each of the 2 sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201324 Mar 2017

First posted9 Oct 2013 (estimated)
Study start1 Oct 2013
Primary completion23 Mar 2017
Study completion24 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Transcranial Direct Current Stimulation
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01958437
Sponsor's protocol ID: C1381-P
Status last verified: Aug 2018
First submitted: 23 Sep 2013
Last updated: 31 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 25647757
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.
PubMed 34602464

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation
ClinicalTrials.gov ID: NCT01958437
Acronym / sponsor ID: C1381-P
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Oct 2013 (actual)
Primary completion: 23 Mar 2017 (actual)
Study completion: 24 Mar 2017 (actual)
First posted: 9 Oct 2013 (estimated)
Results: Posted 31 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4
Model description: Transcranial Direct Current Stimulation

Arm	Type	Receives
Cognitively intact older adults - ACTIVE tDCS	Experimental	Device: Transcranial direct current stimulation (tDCS)Group receives active brain stimulation
MCI ACTIVE tDCS	Active comparator	Device: Transcranial direct current stimulation (tDCS)Group receives active brain stimulation
Cognitively intact older adults - SHAM tDCS	Sham comparator	Device: Transcranial direct current stimulation (tDCS)Group receives sham brain stimulation
MCI SHAM tDCS	Sham comparator	Device: Transcranial direct current stimulation (tDCS)Group receives sham brain stimulation

Who may qualify

Ages: 50 to 88 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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).	Device	Cognitively intact older adults - ACTIVE tDCS, Cognitively intact older adults - SHAM tDCS, MCI ACTIVE tDCS, MCI SHAM tDCS

Primary outcome

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.
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.
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.
Egocentric
Time frame: Outcome assessed after each of the 2 sessions
Number of turns correctly recalled for each egocentric environment

Results and safety

Results posted to the registry on 31 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cognitively Intact -Active Then Sham tDCS	11	11
Cognitively Intact - Sham Then Active	11	11
MCI - Active Then Sham	11	10
MCI - Sham Then Active	11	10

Primary outcome: Accuracy in Centimeters From Target Location for Allocentric

Time frame: Outcome assessed after each of 2 sessions (estimated within 1 week of each other). Mean (Standard Deviation). Unit: Centimeters (cm)

Measure	Cognitively Intact ACTIVE tDCS n = 22	MCI ACTIVE tDCS n = 20	Cognitively Intact SHAM tDCS n = 22	MCI SHAM tDCS n = 20
Value	13.24 (3.96)	15.38 (2.13)	14.22 (2.78)	15.03 (1.77)

Cognitively Intact ACTIVE tDCS vs Cognitively Intact SHAM tDCS: p = .048, ANCOVA
MCI ACTIVE tDCS vs MCI SHAM tDCS: p = .063, ANCOVA

Population analysed: Computer errors caused missing data for a subset (n=4) of participants; those data have simply been omitted from analyses below.

Primary outcome: Hippocampal BOLD Signal During Task-based fMRI

Time frame: change between active and sham tDCS sessions (<1month). Mean (Standard Deviation). Unit: Percent signal change

Measure	MCI ACTIVE tDCS n = 19	MCI Sham HD-tDCS n = 19	Cognitively Intact ACTIVE HD-tDCS n = 19	Cognitively Intact Sham HD-tDCS n = 19
Value	.089 (.12)	.037 (.123)	.143 (.134)	.107 (.117)

MCI ACTIVE tDCS vs MCI Sham HD-tDCS: p = .27, ANCOVA
Cognitively Intact ACTIVE HD-tDCS vs Cognitively Intact Sham HD-tDCS: p <.001, ANCOVA

Population analysed: Participants from each group were excluded due to movement artifact that invalidated fMRI data.

Primary outcome: Dorsal Attention Network Connectivity During Resting-state fMRI

Time frame: change between active and sham tDCS sessions (<1month). Mean (Standard Deviation). Unit: arbitrary units

Measure	Cognitively Intact ACTIVE tDCS n = 20	MCI ACTIVE HD-tDCS n = 18	Cognitively Intact SHAM HD-tDCS n = 20	MCI SHAM HD-tDCS n = 18
Value	29.41 (7.09)	30.93 (11.97)	30.39 (8.2)	31.47 (9.89)

Cognitively Intact ACTIVE tDCS vs Cognitively Intact SHAM HD-tDCS: p <.001, ANCOVA
MCI ACTIVE HD-tDCS vs MCI SHAM HD-tDCS: p = .046, ANCOVA

Population analysed: Participants from each group were excluded due to movement artifact that invalidated fMRI data.

Primary outcome: Egocentric

Time frame: Outcome assessed after each of the 2 sessions. Mean (Standard Deviation). Unit: Correct turns

Measure	Cognitively Intact ACTIVE tDCS n = 22	MCI ACTIVE tDCS n = 20	Cognitively Intact SHAM tDCS n = 22	MCI SHAM tDCS n = 20
Value	9.05 (3.53)	8.21 (3.08)	9.85 (3.6)	7.47 (2.53)

Cognitively Intact ACTIVE tDCS vs Cognitively Intact SHAM tDCS: p = .497, ANCOVA
MCI ACTIVE tDCS vs MCI SHAM tDCS: p = .599, ANCOVA

Population analysed: Participants from each group were excluded due to movement artifact that invalidated fMRI data.

Adverse events

Time frame: duration of each participant's study related activities (~2 weeks), with monitoring ending following the second tDCS session. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cognitively Intact Active	0 of 22 (0%)	13 of 21 (61.9%)	0 of 22
Cognitively Intact Sham	0 of 22 (0%)	17 of 22 (77.3%)	0 of 22
MCI Active	0 of 20 (0%)	15 of 20 (75%)	0 of 20
MCI Sham	0 of 20 (0%)	12 of 20 (60%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25647757England 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.
Derived from this study: PubMed 34602464Lengu 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Benjamin M Hampstead, PhD principal investigator

VA Ann Arbor Healthcare System, Ann Arbor, MI

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy in Centimeters From Target Location for Allocentric (time frame: Outcome assessed after each of 2 sessions (estimated within 1 week of each other)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01958437, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.