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Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by VA Office of Research and Development
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02155946
First received: May 29, 2014
Last updated: April 3, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Mild Cognitive Impairment Alzheimer's Disease Device: Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Functional MRI [ Time Frame: 3 months ]
    Changes in task related and resting state BOLD activation.

  • Face-name memory test performance [ Time Frame: change from baseline ]
    Performance measured using percent correct

  • Object Location Association memory test performance [ Time Frame: change from baseline ]
    Performance measured using deviation from target position

  • fMRI [ Time Frame: change from baseline to 3 months ]
    Changes in task related and resting state BOLD activation.

  • Face-name memory test performance [ Time Frame: change from baseline to 3 months ]
    Performance measured using percent correct

  • Object Location Association memory test performance [ Time Frame: change from baseline to 3 months ]
    Performance measured using deviation from target position


Secondary Outcome Measures:
  • Objective memory test performance [ Time Frame: 3 months ]
    Performance on prose (medical instructions) and spatial (navigation) memory tasks

  • Subjective memory test performance on the MMQ [ Time Frame: 3 months ]
    Changes on the Multifactorial Memory Questionnaire

  • Objective memory test performance [ Time Frame: change from baseline to 3 months ]
    Performance on prose (medical instructions) and spatial (navigation) memory tasks

  • Subjective memory test performance on the MMQ [ Time Frame: change from baseline to 3 months ]
    Changes on the Multifactorial Memory Questionnaire


Other Outcome Measures:
  • Planned (tertiary) analyses of patient-specific characteristics that affect treatment outcome [ Time Frame: post treatment (within ~ 96 hours) & 3 months ]
    Planned analyses to examine patient specific characteristics that affect treatment efficacy and would be vital for clinical translation at the individual patient level. These include: Neuropsychological test scores, brain volumes/cortical thickness, and other possible MRI factors.


Estimated Enrollment: 100
Actual Study Start Date: December 1, 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Group receives active brain stimulation plus memory rehabilitation
Device: Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
Active brain stimulation
Sham Comparator: Arm 2
Group receives sham brain stimulation plus memory rehabilitation
Device: Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
Sham (placebo)
Active Comparator: Arm 3
Group receives active brain stimulation plus reminiscence training
Device: Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
Active brain stimulation
Active Comparator: Arm 4
Group receives sham brain stimulation plus reminiscence training
Device: Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
Sham (placebo)

  Eligibility

Ages Eligible for Study:   50 Years to 88 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02155946

Contacts
Contact: Benjamin M Hampstead, PhD (404) 321-6111 ext 5006 bhampste@med.umich.edu
Contact: Oliver C Calhoun occ@med.umich.edu

Locations
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Benjamin M Hampstead, PhD    404-321-6111 ext 5006    bhampste@med.umich.edu   
Principal Investigator: Benjamin M Hampstead, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Benjamin M Hampstead, PhD VA Ann Arbor Healthcare System, Ann Arbor, MI
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02155946     History of Changes
Other Study ID Numbers: N1534-R
Study First Received: May 29, 2014
Last Updated: April 3, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:
Aging
Alzheimer's Disease/Dementia
Cognitive Disorders
Imaging
Magnetic Resonance Imaging (MRI)
Neurology
Physical Medicine & Rehabilitation
transcranial direct current stimulation

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 23, 2017