Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment

Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment

Sponsors

Lead sponsor: VA Office of Research and Development

Source VA Office of Research and Development
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.

Overall Status Active, not recruiting
Start Date December 1, 2014
Completion Date December 31, 2020
Primary Completion Date December 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Functional MRI 3 months
Face-name memory test performance change from baseline
Object Location Association memory test performance change from baseline
fMRI change from baseline to 3 months
Face-name memory test performance change from baseline to 3 months
Object Location Association memory test performance change from baseline to 3 months
Secondary Outcome
Measure Time Frame
Objective memory test performance 3 months
Subjective memory test performance on the MMQ 3 months
Objective memory test performance change from baseline to 3 months
Subjective memory test performance on the MMQ change from baseline to 3 months
Enrollment 100
Condition
Intervention

Intervention type: Device

Intervention name: Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit

Description: Active brain stimulation

Intervention type: Device

Intervention name: Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit

Description: Sham (placebo)

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

Gender: All

Minimum age: 50 Years

Maximum age: 88 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Benjamin M. Hampstead, PhD Principal Investigator VA Ann Arbor Healthcare System, Ann Arbor, MI
Location
facility
VA Ann Arbor Healthcare System, Ann Arbor, MI
Location Countries

United States

Verification Date

May 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: Arm 1

Arm group type: Experimental

Description: Group receives active brain stimulation plus memory rehabilitation

Arm group label: Arm 2

Arm group type: Sham Comparator

Description: Group receives sham brain stimulation plus memory rehabilitation

Arm group label: Arm 3

Arm group type: Active Comparator

Description: Group receives active brain stimulation plus reminiscence training

Arm group label: Arm 4

Arm group type: Active Comparator

Description: Group receives sham brain stimulation plus reminiscence training

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov