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Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT02155946
Recruitment Status : Recruiting
First Posted : June 4, 2014
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE May 29, 2014
First Posted Date  ICMJE June 4, 2014
Last Update Posted Date March 11, 2019
Actual Study Start Date  ICMJE December 1, 2014
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2016)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
  • Functional MRI [ Time Frame: 3 months ]
    Changes in task related and resting state BOLD activation.
  • Subjective memory test performance on the MMQ [ Time Frame: 3 months ]
    Changes on the Multifactorial Memory Questionnaire
  • Objective memory test performance on neuropsychological tests [ Time Frame: 3 months ]
    Standardized neuropsychological tests of learning and memory (Face-name and Object-Location associations)
Change History Complete list of historical versions of study NCT02155946 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE
 (submitted: January 21, 2016)
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.
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment
Official Title  ICMJE Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment
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

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.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Mild Cognitive Impairment
  • Alzheimer's Disease
Intervention  ICMJE
  • Device: Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
    Active brain stimulation
  • Device: Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
    Sham (placebo)
Study Arms
  • Experimental: Arm 1
    Group receives active brain stimulation plus memory rehabilitation
    Intervention: Device: Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
  • Sham Comparator: Arm 2
    Group receives sham brain stimulation plus memory rehabilitation
    Intervention: Device: Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
  • Active Comparator: Arm 3
    Group receives active brain stimulation plus reminiscence training
    Intervention: Device: Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
  • Active Comparator: Arm 4
    Group receives sham brain stimulation plus reminiscence training
    Intervention: Device: Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 21, 2016)
100
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2014)
200
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 88 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Benjamin M Hampstead, PhD (404) 321-6111 ext 5006 bhampste@med.umich.edu
Contact: Julia Laing, BS (734) 764-4709 laingjul@med.umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02155946
Other Study ID Numbers  ICMJE N1534-R
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benjamin M. Hampstead, PhD VA Ann Arbor Healthcare System, Ann Arbor, MI
PRS Account VA Office of Research and Development
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP