Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment
Condition: Mild Cognitive Impairment; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

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.
    

Detailed description: 
      Enrollment and interactions/interventions are temporarily paused due to COVID-19 and are
      expected to resume in the future. This is not a suspension of IRB approval.

      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 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.

      The general purpose of this study is to examine the effects of two types of treatments for
      memory impairment in those with mild cognitive impairment (MCI). One form of treatment is
      cognitive rehabilitation, which involves teaching new ways to learn and remember information.
      The second form of treatment uses a type of electrical brain stimulation called transcranial
      direct current stimulation (tDCS) to increase activity in certain brain areas that may be
      involved with memory. We will use brain imaging to see whether these treatments changed how
      individuals learn and remember information. We will also use cognitive tests and
      questionnaires to examine whether memory (and related abilities) changed because of
      treatment.

      Values were updated in February 2023 after discovering coding errors in the original
      database. An exploratory outcome variable (effect of brain volumes) was removed at that time
      since the electrical field analyses are fundamentally dependent on brain volumes - the EF
      outcome measure remained but was modified to remove the two sham conditions since, by design,
      they did not receive any electric field (i.e., sham) and the statistical corrections could
      not be performed.
    

Intervention name(s): Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit; Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
Intervention type(s): Device; Device
Intervention description(s): Active brain stimulation; Sham (placebo)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Aging; Alzheimer's Disease/Dementia; Cognitive Disorders; Imaging; Magnetic Resonance Imaging (MRI); Neurology; Physical Medicine & Rehabilitation; transcranial direct current stimulation