Stimulation to Improve Memory

Mild Cognitive Impairment Clinical Trial

— STIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03875326
• Other study ID #: HUM00146180
• Secondary ID: 1R01AG058724
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: Stephen M Schlaefflin, BS
• Phone: 734-936-7360
• Email: schlst[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Dementia of Alzheimer Type
• Mild Cognitive Impairment

Intervention

Device:
• 1 mA HD-tDCS
Participants will receive HD-tDCS at 1 mA for 30 minutes, for between 5-30 sessions.
• 2 mA HD-tDCS
Participants will receive HD-tDCS at 2 mA for 30 minutes, for between 5-30 sessions.
• 3 mA HD-tDCS
Participants will receive HD-tDCS at 3 mA for 30 minutes, for between 5-30 sessions.
• Sham
Participants will receive sham (placebo) HD-tDCS for 30 minutes, for between 5-30 sessions.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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
Other	Change in Global Cognition	Measured through change in the Total RBANS Score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Other	Change in Visuospatial Functioning	Measured through change in the RBANS Visuospatial Index score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Other	Change in Language Functioning	Measured through change in the RBANS Language Index score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Other	Change in Attention	Measured through change in the RBANS Attention Index score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Other	Change in Memory Functioning	Measured through change in the RBANS Immediate Memory Index score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Other	Change in Cognitive Functioning	A priori intent to measure through changes in RBANS subtest scores	Baseline and post-intervention (after tDCS sessions 5 & 30)
Other	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
Primary	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	Self-Report of Contentment with Memory	Multifactorial Memory Questionnaire (MMQ) Contentment Score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Secondary	Self-Report of Memory Mistakes	Multifactorial Memory Questionnaire (MMQ) Ability Score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Secondary	Self-Report of Memory Strategies Used	Multifactorial Memory Questionnaire (MMQ) Strategies Score	Baseline and post-intervention (after tDCS sessions 5 & 30)
Secondary	Change in Memory Functioning	Measured through change in the RBANS Delayed Memory Index	Baseline and post-intervention (after tDCS sessions 5 & 30)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)