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NCT01958437

Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation

Completed NA Results posted Last updated 31 August 2018
What this trial tests

NA trial testing Transcranial direct current stimulation (tDCS) in Mild Cognitive Impairment in 44 participants. Completed in 24 March 2017.

Timeline
1 October 2013
Primary endpoint
23 March 2017
24 March 2017

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment44
Start date1 October 2013
Primary completion23 March 2017
Estimated completion24 March 2017
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 50 to 88, any sex, with Mild Cognitive Impairment or Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Accuracy in Centimeters From Target Location for Allocentric Primary · 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.

GroupValue95% CI
Cognitively Intact ACTIVE tDCS13.24± 3.96
MCI ACTIVE tDCS15.38± 2.13
Cognitively Intact SHAM tDCS14.22± 2.78
MCI SHAM tDCS15.03± 1.77
Hippocampal BOLD Signal During Task-based fMRI Primary · 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.

GroupValue95% CI
MCI ACTIVE tDCS.089± .12
MCI Sham HD-tDCS.037± .123
Cognitively Intact ACTIVE HD-tDCS.143± .134
Cognitively Intact Sham HD-tDCS.107± .117
Dorsal Attention Network Connectivity During Resting-state fMRI Primary · 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.

GroupValue95% CI
Cognitively Intact ACTIVE tDCS29.41± 7.09
MCI ACTIVE HD-tDCS30.93± 11.97
Cognitively Intact SHAM HD-tDCS30.39± 8.2
MCI SHAM HD-tDCS31.47± 9.89
Egocentric Primary · Outcome assessed after each of the 2 sessions

Number of turns correctly recalled for each egocentric environment

GroupValue95% CI
Cognitively Intact ACTIVE tDCS9.05± 3.53
MCI ACTIVE tDCS8.21± 3.08
Cognitively Intact SHAM tDCS9.85± 3.6
MCI SHAM tDCS7.47± 2.53

Adverse events — posted to ClinicalTrials.gov

Time frame: duration of each participant's study related activities (~2 weeks), with monitoring ending following the second tDCS session. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cognitively Intact Active
Serious: 0/22 (0%)
Deaths: 0/22
Cognitively Intact Sham
Serious: 0/22 (0%)
Deaths: 0/22
MCI Active
Serious: 0/20 (0%)
Deaths: 0/20
MCI Sham
Serious: 0/20 (0%)
Deaths: 0/20
Other adverse events (10 terms — click to expand)

ReactionSystemCognitively Intact ActiveCognitively Intact ShamMCI ActiveMCI Sham
Side effect questionnaireSkin and subcutaneous tissue disorders
Side effect questionnaireSkin and subcutaneous tissue disorders
Side effect questionnaireSkin and subcutaneous tissue disorders
Side effect questionnaireSkin and subcutaneous tissue disorders
Side effect questionnaireSkin and subcutaneous tissue disorders
Side effect questionnaireSkin and subcutaneous tissue disorders
Side effect questionnaireSkin and subcutaneous tissue disorders
Side effect questionnaireSkin and subcutaneous tissue disorders
Side effect questionnaireSkin and subcutaneous tissue disorders
Side effect questionnaireSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT01958437 adverse events section.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps.
    Reckow J, Rahman-Filipiak A, Garcia S, Schlaefflin S, et al · · 2018 · cited 74× · PMID 29784589 · DOI 10.1016/j.brs.2018.04.022
  2. Advances in neurocognitive rehabilitation research from 1992 to 2017: The ascension of neural plasticity.
    Crosson B, Hampstead BM, Krishnamurthy LC, Krishnamurthy V, et al · · 2017 · cited 20× · PMID 28857600 · DOI 10.1037/neu0000396
  3. Tolerability and blinding of high-definition transcranial direct current stimulation among older adults at intensities of up to 4 mA per electrode.
    El Jamal C, Harrie A, Rahman-Filipiak A, Iordan AD, et al · · 2023 · cited 19× · PMID 37660936 · DOI 10.1016/j.brs.2023.08.025
  4. High-definition transcranial direct current stimulation enhances network segregation during spatial navigation in mild cognitive impairment.
    Iordan AD, Ryan S, Tyszkowski T, Peltier SJ, et al · · 2022 · cited 19× · PMID 35134853 · DOI 10.1093/cercor/bhac010
  5. 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.
    Lengu K, Ryan S, Peltier SJ, Tyszkowski T, et al · · 2021 · cited 13× · PMID 34602464 · DOI 10.3233/jad-201091
  6. The Potential for Neuromodulation in the Treatment of Alzheimer's Disease: A Review of Clinical Trials.
    Jones T, Shalom M, Chalamgari A, Gold J, et al · · 2025 · PMID 40599507 · DOI 10.7759/cureus.85156

Verify or expand the search:

Other trials of Transcranial direct current stimulation (tDCS)

Trials testing the same drug.

Other recruiting trials for Mild Cognitive Impairment

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

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