Stimulation to Improve Memory

Not Applicable

Recruiting

• Conditions: Dementia of Alzheimer Type; Mild Cognitive Impairment
• Interventions: Device: 1 mA HD-tDCS; Device: Sham; Device: 3 mA HD-tDCS; Device: 2 mA HD-tDCS

• Registration Number: NCT03875326
• Lead Sponsor: 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) and dementia of the Alzheimer's Type (DAT).

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 Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-14
• Study Start: 2019-04-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 mA Dosage Stimulation	1 mA HD-tDCS	1 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
Sham Stimulation	Sham	Sham (placebo) dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
3 mA Dosage Stimulation	3 mA HD-tDCS	3 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
2 mA Dosage Stimulation	2 mA HD-tDCS	2 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Self-Report of Contentment with Memory	Baseline and post-intervention (after tDCS sessions 5 & 30)	Multifactorial Memory Questionnaire (MMQ) Contentment Score
Change in Overall Fluid Cognitive Abilities	Baseline and post-intervention (after tDCS sessions 5 & 30)	Measured through change in the NIH Toolbox Cognition Fluid Composite Score
Cumulative Working Memory Effects of HD-tDCS across daily sessions	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)
Cumulative Memory Reaction Time Effects of HD-tDCS across daily sessions	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)
Change in Memory Functioning	Baseline and post-intervention (after tDCS sessions 5 & 30)	Measured through change in the RBANS Delayed Memory Index
Cumulative Memory Accuracy Effects of HD-tDCS across daily sessions	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)
Self-Report of Memory Mistakes	Baseline and post-intervention (after tDCS sessions 5 & 30)	Multifactorial Memory Questionnaire (MMQ) Ability Score
Self-Report of Memory Strategies Used	Baseline and post-intervention (after tDCS sessions 5 & 30)	Multifactorial Memory Questionnaire (MMQ) Strategies Score
Tolerability of HD-tDCS	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).
Effectiveness of Blinding of HD-tDCS	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).

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States