Stimulation to Improve Memory (STIM)

Testing High Definition Transcranial Direct Current Stimulation (HD-tDCS) as Treatment of Mild Cognitive Impairment

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).

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment; Dementia of Alzheimer Type
• Intervention / Treatment: Device: Sham; Device: 1 mA HD-tDCS; Device: 2 mA HD-tDCS; Device: 3 mA HD-tDCS

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 Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen M Schlaefflin, BS; Phone Number: 734-936-7360; Email: schlst@med.umich.edu
• Study Contact Backup: Name: Eileen A Robinson, RN-BC; Phone Number: 734-763-1356; Email: robinsoe@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Recruiting
      • University of Michigan
      • Contact: Stephen M Schlaefflin, BS; Phone Number: 734-936-7360; Email: schlst@med.umich.edu
      • Contact: Eileen Robinson, RN-BC, MPH, CCRC; Phone Number: 734-763-1356; Email: robinsoe@med.umich.edu
      • Principal Investigator: Benjamin Hampstead, PhD
      • Sub-Investigator: Annalise Rahman-Filipiak, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lateral Temporal Cortex Connectivity	Graph Theory Analysis via fMRI using arbitrary units of connectivity strength	Baseline fMRI and post-intervention (after tDCS sessions 5 & 30)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Report of Contentment with Memory	Multifactorial Memory Questionnaire (MMQ) Contentment Score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Self-Report of Memory Mistakes	Multifactorial Memory Questionnaire (MMQ) Ability Score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Self-Report of Memory Strategies Used	Multifactorial Memory Questionnaire (MMQ) Strategies Score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Change in Memory Functioning	Measured through change in the RBANS Delayed Memory Index	Baseline and post-intervention (after tDCS sessions 5 & 30)
Change in Overall Fluid Cognitive Abilities	Measured through change in the NIH Toolbox Cognition Fluid Composite Score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Cumulative Working Memory Effects of HD-tDCS across daily sessions	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)	Baseline Session through Session 6 then weekly up to final session
Cumulative Memory Accuracy Effects of HD-tDCS across daily sessions	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)	Baseline Session through Session 6 then weekly up to final session
Cumulative Memory Reaction Time Effects of HD-tDCS across daily sessions	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)	Baseline Session through Session 6 then weekly up to final session
Tolerability of HD-tDCS	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).	Prior to and immediately following each HD-tDCS session (<60 Minutes)
Effectiveness of Blinding of HD-tDCS	Evaluated using a standard single question administered after every brain stimulation session (including sham).	Immediately following HD-tDCS sessions 5 and final session (<60 Minutes)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Default Mode Network Connectivity	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	Baseline fMRI and post-intervention (after tDCS sessions 5 & 30)
Change in Inhibition Ability	A priori intent to measure through change in the NIH Toolbox Flanker Inhibitory Control and Attention Test Score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Change in Conceptualization Ability	A priori intent to measure through change in the NIH Toolbox Dimensional Change Card Sort Test Score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Change in Picture Sequence Memory	A priori intent to measure through change in the NIH Toolbox Picture Sequence Memory Test Score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Change in Working Memory Ability	A priori intent to measure through change in the NIH Toolbox List Sorting Working Memory Test Score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Change in Processing Speed	A priori intent to measure through change in the NIH Toolbox Pattern Comparison Processing Speed Test Score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Cumulative Working Memory Performance Effects of HD-tDCS across daily sessions	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.	Baseline Session through Session 6 then weekly up to final session
Change in Global Cognition	Measured through change in the Total RBANS Score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Change in Visuospatial Functioning	Measured through change in the RBANS Visuospatial Index score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Change in Language Functioning	Measured through change in the RBANS Language Index score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Change in Attention	Measured through change in the RBANS Attention Index score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Change in Memory Functioning	Measured through change in the RBANS Immediate Memory Index score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Change in Cognitive Functioning	A priori intent to measure through changes in RBANS subtest scores	Baseline and post-intervention (after tDCS sessions 5 & 30)
Cumulative Cognitive Change across Daily Consecutive Sessions	Measured through change in Cogstate or other comparable computerized cognitive testing scores across consecutive daily sessions	After each HD-tDCS Session, daily

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Benjamin Hampstead, PhD, Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: PET scan; Dementia; fMRI; Memory; Cognitive Rehabilitation; Brain Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Cognition Disorders; Dementia; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: HUM00146180; 1R01AG058724 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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