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Stimulation to Improve Memory (STIM)

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ClinicalTrials.gov Identifier: NCT03875326
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 3, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Benjamin Hampstead, PhD, University of Michigan

Study Description
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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) and dementia of the Alzheimer's Type (DAT).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Dementia of Alzheimer Type 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) and dementia of the Alzheimer's type (DAT). 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 or DAT. It is expected but not required that participants will be co-enrolled in the University of Michigan Memory and Aging Project (UM-MAP; HUM00000382).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 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 at least 5 sessions and up to 30 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) as Treatment of Mild Cognitive Impairment
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : October 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Sham Stimulation
Sham (placebo) dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
 Device: Sham
Participants will receive sham (placebo) HD-tDCS for 30 minutes, for between 5-30 sessions.
Experimental: 1 mA Dosage Stimulation
1 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
 Device: 1 mA HD-tDCS
Participants will receive HD-tDCS at 1 mA for 30 minutes, for between 5-30 sessions.
Experimental: 2 mA Dosage Stimulation
2 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
 Device: 2 mA HD-tDCS
Participants will receive HD-tDCS at 2 mA for 30 minutes, for between 5-30 sessions.
Experimental: 3 mA Dosage Stimulation
3 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
 Device: 3 mA HD-tDCS
Participants will receive HD-tDCS at 3 mA for 30 minutes, for between 5-30 sessions.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Lateral Temporal Cortex Connectivity [ Time Frame: Baseline fMRI and post-intervention (after tDCS sessions 5 & 30) ]
    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 post-intervention (after tDCS sessions 5 & 30) ]
    Multifactorial Memory Questionnaire (MMQ) Contentment Score

  2. Self-Report of Memory Mistakes [ Time Frame: Baseline and post-intervention (after tDCS sessions 5 & 30) ]
    Multifactorial Memory Questionnaire (MMQ) Ability Score

  3. Self-Report of Memory Strategies Used [ Time Frame: Baseline and post-intervention (after tDCS sessions 5 & 30) ]
    Multifactorial Memory Questionnaire (MMQ) Strategies Score

  4. Change in Memory Functioning [ Time Frame: Baseline and post-intervention (after tDCS sessions 5 & 30) ]
    Measured through change in the RBANS Delayed Memory Index

  5. Change in Overall Fluid Cognitive Abilities [ Time Frame: Baseline and post-intervention (after tDCS sessions 5 & 30) ]
    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 then weekly up to final session ]
    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 then weekly up to final session ]
    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 then weekly up to final session ]
    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 each HD-tDCS session (<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 sessions 5 and final session (<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 post-intervention (after tDCS sessions 5 & 30) ]
    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 and post-intervention (after tDCS sessions 5 & 30) ]
    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 and post-intervention (after tDCS sessions 5 & 30) ]
    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 and post-intervention (after tDCS sessions 5 & 30) ]
    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 and post-intervention (after tDCS sessions 5 & 30) ]
    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 and post-intervention (after tDCS sessions 5 & 30) ]
    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 then weekly up to final session ]
    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 Global Cognition [ Time Frame: Baseline and post-intervention (after tDCS sessions 5 & 30) ]
    Measured through change in the Total RBANS Score

  9. Change in Visuospatial Functioning [ Time Frame: Baseline and post-intervention (after tDCS sessions 5 & 30) ]
    Measured through change in the RBANS Visuospatial Index score

  10. Change in Language Functioning [ Time Frame: Baseline and post-intervention (after tDCS sessions 5 & 30) ]
    Measured through change in the RBANS Language Index score

  11. Change in Attention [ Time Frame: Baseline and post-intervention (after tDCS sessions 5 & 30) ]
    Measured through change in the RBANS Attention Index score

  12. Change in Memory Functioning [ Time Frame: Baseline and post-intervention (after tDCS sessions 5 & 30) ]
    Measured through change in the RBANS Immediate Memory Index score

  13. Change in Cognitive Functioning [ Time Frame: Baseline and post-intervention (after tDCS sessions 5 & 30) ]
    A priori intent to measure through changes in RBANS subtest scores

  14. Cumulative Cognitive Change across Daily Consecutive Sessions [ Time Frame: After each HD-tDCS Session, daily ]
    Measured through change in Cogstate or other comparable computerized cognitive testing scores across consecutive daily sessions


Eligibility Criteria
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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 (MCI) or dementia of the Alzheimer's type (DAT)
  2. 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)
  3. 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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: Stephen M Schlaefflin, BS 734-936-7360 schlst@med.umich.edu
Contact: Eileen A Robinson, RN-BC 734-763-1356 robinsoe@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Stephen M Schlaefflin, BS    734-936-7360    schlst@med.umich.edu   
Contact: Eileen Robinson, RN-BC, MPH, CCRC    734-763-1356    robinsoe@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
More Information
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Responsible Party: Benjamin Hampstead, PhD, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03875326    
Other Study ID Numbers: HUM00146180
1R01AG058724 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: March 2022
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
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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Dementia
Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Tauopathies
Neurodegenerative Diseases