Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02155946
Recruitment Status : Completed
First Posted : June 4, 2014
Last Update Posted : September 21, 2021
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 September 21, 2021
Actual Study Start Date  ICMJE December 1, 2014
Actual Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2021)
  • Face-name memory test performance [ Time Frame: change from baseline to post, baseline to 3 month follow-up, and post to 3 month follow-up ]
    Performance measured using percent correct
  • Object Location Association memory test performance [ Time Frame: change from baseline to post, baseline to 3 month follow-up, and post to 3 month follow-up ]
    Performance measured using deviation from target position
  • fMRI [ Time Frame: change from baseline to post, baseline to 3 month follow-up, and post to 3 month follow-up ]
    Changes in task related and resting state BOLD activation/connectivity.
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
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2021)
  • Objective memory test performance [ Time Frame: change from baseline to post, baseline to 3 month follow-up, and post to 3 month follow-up ]
    Performance on prose (medical instructions) and spatial (navigation) memory tasks
  • Subjective memory test performance on the MMQ [ Time Frame: change from baseline to post, baseline to 3 month follow-up, and post to 3 month follow-up ]
    Changes on the Multifactorial Memory Questionnaire
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: September 15, 2021)
  • Planned (tertiary) analyses of patient-specific characteristics that affect treatment outcome [ Time Frame: change from baseline 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. Effect of level of cognitive functioning, measured via neuropsychological test performance at baseline, will be evaluated on magnitude of change at post-treatment and 3 month follow-up. Scores range from -3 to +3 standard deviations.
  • Electric field effects [ Time Frame: change from baseline post treament (within ~96 hours) ]
    Finite element model based measurement of electric field in the targeted brain regions (Values range from 0 to no theoretical upper limit with higher values reflecting more electrical current; most values will be under 0.5 V/m)
  • Brain morphology [ Time Frame: Measured at baseline ]
    Magnetic Resonance Imaging based measure of brain volume (in percent of intracranial volume; higher values reflect larger brain size)
Original Other Pre-specified Outcome Measures 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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE 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  ICMJE
  • 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 Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2021)
107
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2014)
200
Actual Study Completion Date  ICMJE March 31, 2021
Actual Primary Completion Date February 28, 2021   (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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 88 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
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 September 2021

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