Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment

NCT02155946 | Completed Results FDA Device

• 1 other identifier: N1534-R
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Face-name Memory Test Performance

  Raw number of face-name pairs correctly recalled with a maximum of 15 points; higher values are better at each time point. Change at post-session 5 (day 5 after baseline)) calculated relative to baseline performance (positive differences indicate improvement; negative values indicate decline). Data coding errors were identified and accurate values were reported 2/6/2023.

  change from baseline to post session 5 (day 5 after baseline)

• Object Location Association Memory Test Performance - Recognition Condition

  Performance measured using number of correctly identified locations (3 locations per stimulus; 15 total stimuli). Higher values indicate better performance. Change at post-session 5 (day 5 after baseline) calculated relative to baseline performance (positive differences indicate improvement; negative values indicate decline). Data coding errors were identified and accurate data were updated 2/6/2023.

  change from baseline to post session 5 (day 5 after baseline)

• fMRI Betaweight Change

  Changes in task related blood oxygen dependent signal (BOLD) activation for the face-name (novel post \> novel pre) contrast in the left inferior frontal gyrus (pars triangularis, pars orbitalis, pars opercularis). Data are preliminary betaweights for the above noted contrast. Positive values reflect increased BOLD signal while negative values represent reduced BOLD signal. Not all participants were able to complete fMRI, which explains sample size discrepancies with other outcome measures. Data coding errors were discovered and accurate, updated data reported on 2/6/2023

  change from baseline to post session 5 (day 5 after baseline)

Secondary Outcomes (3)

• Prose Memory

  change from baseline to post Session 5 (day 5 after baseline)

• MMQ - Strategy Subscale

  change from baseline to post session 5 (day 5 after baseline)

• Spatial Navigation

  change from baseline to post session 5 (day 5 after baseline)

Other Outcomes (2)

• Planned (Tertiary) Analyses of Patient-specific Characteristics That Affect Treatment Outcome

  change from baseline post treatment (within ~ 96 hours of session 5)

• Change in Beta-weights Controlling for Electric Field (EF)

  Betaweight change: Post session 5 (day 5) minus baseline

Study Arms (4)

active tDCS + mnemonic strategy training

EXPERIMENTAL

Group receives active brain stimulation plus memory rehabilitation

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

sham tDCS + mnemonic strategy training

ACTIVE COMPARATOR

Group receives sham brain stimulation plus memory rehabilitation

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

active tDCS + autobiographical memory recall

ACTIVE COMPARATOR

Group receives active brain stimulation plus reminiscence training

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

sham tDCS + autobiographical memory recall

ACTIVE COMPARATOR

Group receives sham brain stimulation plus reminiscence training

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

Interventions

Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit DEVICE

Active brain stimulation

active tDCS + autobiographical memory recall; active tDCS + mnemonic strategy training

Eligibility Criteria

• Age: 50 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Dementia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. Benjamin Hampstead
• Organization: VA Ann Arbor

bhampste@med.umich.edu

734-763-9259

Study Officials

• Benjamin M. Hampstead, PhD

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 4, 2014
• Study Start: December 1, 2014
• Primary Completion: February 28, 2021
• Study Completion: March 31, 2021
• Last Updated: November 30, 2023
• Results First Posted: September 1, 2022

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)