Mode
Text Size
Log in / Sign up
N/A N=107 Randomized Double-blind Treatment

Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment

Mild Cognitive Impairment · Alzheimer's Disease

Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Face-name Memory Test Performance — -.28; -.01; -1.29; -1.76 pairs correctly recalled/recognized

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit (Device)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Feb 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Face-name Memory Test Performance
-.28; -.01; -1.29; -1.76
PRIMARY
Object Location Association Memory Test Performance - Recognition Condition
.55; .25; .07; -.76
PRIMARY
fMRI Betaweight Change
.34; -.09; .07; -.13
SECONDARY
Prose Memory
-1.07; -1.18; -.93; -1.56
SECONDARY
MMQ - Strategy Subscale
1.41; 1.1; -1.9; -.5
SECONDARY
Spatial Navigation
.59; .74; 1.03; .6

Summary

The aging US population threatens to overwhelm our healthcare infrastructure, especially since the rate of Alzheimer's disease (AD) alone is expected to triple in the coming decades. Memory cause functional impairment, reduced quality of life, increased caregiver burnout, and eventual institutionalization. The diagnosis of mild cognitive impairment (MCI) identifies those with memory deficits but who remain relatively independent in everyday life. MCI provides a window for interventions that target memory functioning. The proposed study focuses specifically on a groundbreaking combination of mnemonic rehabilitation and non-invasive brain stimulation. The main idea is that brain stimulation can enhance functioning in the specific brain regions/networks, thereby increasing the patients' ability to benefit from different types of memory rehabilitation. This will be a randomized, double-blind study (active vs. fake brain stimulation), that provides multiple treatment session. Outcome will be examined using both laboratory-based and real-world memory testing as well as brain imaging. This first-of-its-kind study has the potential to meaningfully translate more "basic" science findings into neuroanatomically targeted and functionally meaningful treatments for our aging population.

Eligibility Criteria

Inclusion Criteria

General inclusion criteria (all patients):

  • All medications stable for approximately 2-3 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

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02155946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search