Clinical trial NCT02155946: Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment
Official title: Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-06-04
Enrollment: 107
Sex: ALL
Minimum age (years): 50
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Face-name Memory Test Performance
timeFrame: change from baseline to post session 5 (day 5 after baseline)
measure: Object Location Association Memory Test Performance - Recognition Condition
timeFrame: change from baseline to post session 5 (day 5 after baseline)
measure: fMRI Betaweight Change
timeFrame: change from baseline to post session 5 (day 5 after baseline)
Secondary outcomes:
measure: Prose Memory
timeFrame: change from baseline to post Session 5 (day 5 after baseline)
measure: MMQ - Strategy Subscale
timeFrame: change from baseline to post session 5 (day 5 after baseline)
measure: Spatial Navigation
timeFrame: change from baseline to post session 5 (day 5 after baseline)
Other outcomes:
measure: Planned (Tertiary) Analyses of Patient-specific Characteristics That Affect Treatment Outcome
timeFrame: change from baseline post treatment (within ~ 96 hours of session 5)
measure: Change in Beta-weights Controlling for Electric Field (EF)
timeFrame: Betaweight change: Post session 5 (day 5) minus baseline
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Benjamin M. Hampstead, PhD
role: PRINCIPAL_INVESTIGATOR
References: