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Stimulation to Undermine Dementia (STUD)

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ClinicalTrials.gov Identifier: NCT03875326
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Benjamin Hampstead, PhD, University of Michigan

Brief Summary:
This study will test the effects of different doses of a form of non-invasive brain stimulation for the treatment of individuals with mild cognitive impairment (MCI).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Device: 1 mA HD-tDCS Device: 2 mA HD-tDCS Device: 3 mA HD-tDCS Device: Sham Not Applicable

Detailed Description:
This research study is being done to learn important information about the effects of weak electrical stimulation on brain functioning in those with mild cognitive impairment (MCI). The findings will help determine "how much" stimulation is needed to enhance memory and thinking abilities, how it affects brain functioning, and who is most likely to benefit. Ultimately, this information may guide treatment efforts for those at various stages of Alzheimer's disease. The study will use brain imaging to see whether these treatments change how participants learn and remember information. Functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) scans will be used. The study will also use cognitive tests and questionnaires to examine whether participants' memory (and related abilities) change because of treatment. The study will enroll participants with a diagnosis of MCI. It is expected that participants will be co-enrolled in the University of Michigan Memory and Aging Project (UM-MAP; HUM00000382).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible participants will be randomized 1:1:1:1 to receive either sham, 1mA, 2mA, or 3mA HD-tDCS for the entire 5 sessions using a blocked randomization design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testing High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Treatment of Mild Cognitive Impairment
Actual Study Start Date : February 21, 2019
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : October 1, 2023

Arm Intervention/treatment
Sham Comparator: Sham Stimulation
Sham (placebo) dose of HD-tDCS treatment for 30 minutes, for 5 consecutive daily sessions
Device: Sham
Participants will receive sham (placebo) HD-tDCS for 30 minutes, for 5 consecutive daily sessions

Experimental: 1 mA Dosage Stimulation
1 milliAmp dose of HD-tDCS treatment for 30 minutes, for 5 consecutive daily sessions
Device: 1 mA HD-tDCS
Participants will receive HD-tDCS at 1 mA for 30 minutes, for 5 consecutive daily sessions

Experimental: 2 mA Dosage Stimulation
2 milliAmp dose of HD-tDCS treatment for 30 minutes, for 5 consecutive daily sessions
Device: 2 mA HD-tDCS
Participants will receive HD-tDCS at 2 mA for 30 minutes, for 5 consecutive daily sessions

Experimental: 3 mA Dosage Stimulation
3 milliAmp dose of HD-tDCS treatment for 30 minutes, for 5 consecutive daily sessions
Device: 3 mA HD-tDCS
Participants will receive HD-tDCS at 3 mA for 30 minutes, for 5 consecutive daily sessions




Primary Outcome Measures :
  1. Change in Lateral Temporal Cortex Connectivity [ Time Frame: Baseline fMRI and Session 6 (Post fMRI; up to 3 weeks after baseline) ]
    Graph Theory Analysis via fMRI using arbitrary units of connectivity strength


Secondary Outcome Measures :
  1. Self-Report of Contentment with Memory [ Time Frame: Baseline and Session 6 (up to 3 weeks after baseline) ]
    Multifactorial Memory Questionnaire (MMQ) Contentment Score

  2. Self-Report of Memory Mistakes [ Time Frame: Baseline and Session 6 (up to 3 weeks after baseline) ]
    Multifactorial Memory Questionnaire (MMQ) Ability Score

  3. Self-Report of Memory Strategies Used [ Time Frame: Baseline and Session 6 (up to 3 weeks after baseline) ]
    Multifactorial Memory Questionnaire (MMQ) Strategies Score

  4. Change in Global Cognitive Functioning [ Time Frame: Baseline Session and Session 6 (up to 3 weeks after baseline) ]
    Measured through change in the RBANS Total Composite Score

  5. Change in Overall Fluid Cognitive Abilities [ Time Frame: Baseline Session and Session 6 (up to 3 weeks after baseline) ]
    Measured through change in the NIH Toolbox Cognition Fluid Composite Score

  6. Cumulative Working Memory Effects of HD-tDCS across daily sessions [ Time Frame: Baseline Session through Session 6 (up to 3 weeks after baseline) ]
    Working memory accuracy measured by a discriminability ratio (2-back d' minus 0-back d') on a validated computerized N-Back task, measured after baseline (Session 1) and every intervention session (Sessions 2-6)

  7. Cumulative Memory Accuracy Effects of HD-tDCS across daily sessions [ Time Frame: Baseline Session through Session 6 (up to 3 weeks after baseline) ]
    Verbal memory accuracy measured by an accuracy score (percent correct) on a computerized Paired Associates task, measured after baseline (Session 1) and every intervention session (Sessions 2-6)

  8. Cumulative Memory Reaction Time Effects of HD-tDCS across daily sessions [ Time Frame: Baseline Session through Session 6 (up to 3 weeks after baseline) ]
    Verbal memory reaction time measured by a drift rate score (V; measured by the mean rate at which information is accumulated towards a boundary [correct or error response]) on a computerized Paired Associates task, measured after baseline (Session 1) and every intervention session (Sessions 2-6)

  9. Tolerability of HD-tDCS [ Time Frame: Prior to and immediately following HD-tDCS (<60 Minutes) ]
    Evaluated using standard questionnaires that arose from comprehensive reviews of the tDCS literature, this questionnaire was recently refined to include pre- and post-HD-tDCS symptom assessment. This will be administered prior to and immediately after every brain stimulation session (including sham).

  10. Effectiveness of Blinding of HD-tDCS [ Time Frame: Immediately following HD-tDCS (<60 Minutes) ]
    Evaluated using a standard single question administered after every brain stimulation session (including sham).


Other Outcome Measures:
  1. Change in Default Mode Network Connectivity [ Time Frame: Baseline fMRI and Session 6 (Post fMRI; up to 3 weeks after baseline) ]
    Graph Theory Analysis via fMRI using arbitrary units of connectivity strength to measure changes in the Default Mode Network, along with strength in and between other networks

  2. Change in Inhibition Ability [ Time Frame: Baseline Session and Session 6 (up to 3 weeks after baseline) ]
    A priori intent to measure through change in the NIH Toolbox Flanker Inhibitory Control and Attention Test Score

  3. Change in Conceptualization Ability [ Time Frame: Baseline Session and Session 6 (up to 3 weeks after baseline) ]
    A priori intent to measure through change in the NIH Toolbox Dimensional Change Card Sort Test Score

  4. Change in Picture Sequence Memory [ Time Frame: Baseline Session and Session 6 (up to 3 weeks after baseline) ]
    A priori intent to measure through change in the NIH Toolbox Picture Sequence Memory Test Score

  5. Change in Working Memory Ability [ Time Frame: Baseline Session and Session 6 (up to 3 weeks after baseline) ]
    A priori intent to measure through change in the NIH Toolbox List Sorting Working Memory Test Score

  6. Change in Processing Speed [ Time Frame: Baseline Session and Session 6 (up to 3 weeks after baseline) ]
    A priori intent to measure through change in the NIH Toolbox Pattern Comparison Processing Speed Test Score

  7. Cumulative Working Memory Performance Effects of HD-tDCS across daily sessions [ Time Frame: Baseline Session through Session 6 (up to 3 weeks after baseline) ]
    A priori intent to explore d' change for each N-Back task condition (2-back, 0-back) in order to understand the overall effect of the HD-tDCS on task performance.

  8. Change in Learning and Immediate Memory [ Time Frame: Baseline Session and Session 6 (up to 3 weeks after baseline) ]
    Measured through change in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Immediate Memory Index score

  9. Change in Visuospatial Functioning [ Time Frame: Baseline Session and Session 6 (up to 3 weeks after baseline) ]
    Measured through change in the RBANS Visuospatial Index score

  10. Change in Language Functioning [ Time Frame: Baseline Session and Session 6 (up to 3 weeks after baseline) ]
    Measured through change in the RBANS Language Index score

  11. Change in Attention [ Time Frame: Baseline Session and Session 6 (up to 3 weeks after baseline) ]
    Measured through change in the RBANS Attention Index score

  12. Change in Memory Functioning [ Time Frame: Baseline Session and Session 6 (up to 3 weeks after baseline) ]
    Measured through change in the RBANS Delayed Memory Index score

  13. Change in Cognitive Functioning [ Time Frame: Baseline Session and Session 6 (up to 3 weeks after baseline) ]
    A priori intent to measure through changes in RBANS subtest scores



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Mild Cognitive Impairment
  2. Right-handed
  3. Must be MRI compatible, criteria that also apply for High Definition transcranial direct current stimulation (HD-tDCS; e.g., absence of metallic or electronic implants in the upper body or head)
  4. Stable on relevant medications for at least 4 weeks prior to study enrollment

Exclusion Criteria:

  1. Certain neurological diseases
  2. Certain psychiatric conditions
  3. Severe sensory impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875326


Contacts
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Contact: Rachael Snyder, BS 734-936-7360 rlsnyder@med.umich.edu
Contact: Colin Pietron, BA 734-764-6447 pietroce@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Rachael Snyder, BS    734-936-7360    rlsnyder@med.umich.edu   
Contact: Arijit Bhaumik, BA    734-936-8281    arijit@med.umich.edu   
Principal Investigator: Benjamin Hampstead, PhD         
Sub-Investigator: Annalise Rahman-Filipiak, PhD         
Sponsors and Collaborators
University of Michigan
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Benjamin Hampstead, PhD Associate Professor

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Responsible Party: Benjamin Hampstead, PhD, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03875326     History of Changes
Other Study ID Numbers: HUM00146180
1R01AG058724 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Benjamin Hampstead, PhD, University of Michigan:
Dementia
Memory
Cognitive Rehabilitation
PET scan
fMRI
Brain Stimulation
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders