Clinical trial NCT03875326: Stimulation to Improve Memory
Official title: Testing High Definition Transcranial Direct Current Stimulation (HD-tDCS) as Treatment of Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Dementia of Alzheimer Type
Keywords: Dementia
Memory
Cognitive Rehabilitation
PET scan
fMRI
Brain Stimulation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-03-14
Enrollment: 240
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Change in Lateral Temporal Cortex Connectivity
timeFrame: Baseline fMRI and post-intervention (after tDCS sessions 5 & 30)
Secondary outcomes:
measure: Self-Report of Contentment with Memory
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Self-Report of Memory Mistakes
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Self-Report of Memory Strategies Used
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Change in Memory Functioning
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Change in Overall Fluid Cognitive Abilities
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Cumulative Working Memory Effects of HD-tDCS across daily sessions
timeFrame: Baseline Session through Session 6 then weekly up to final session
measure: Cumulative Memory Accuracy Effects of HD-tDCS across daily sessions
timeFrame: Baseline Session through Session 6 then weekly up to final session
measure: Cumulative Memory Reaction Time Effects of HD-tDCS across daily sessions
timeFrame: Baseline Session through Session 6 then weekly up to final session
measure: Tolerability of HD-tDCS
timeFrame: Prior to and immediately following each HD-tDCS session (<60 Minutes)
measure: Effectiveness of Blinding of HD-tDCS
timeFrame: Immediately following HD-tDCS sessions 5 and final session (<60 Minutes)
Other outcomes:
measure: Change in Default Mode Network Connectivity
timeFrame: Baseline fMRI and post-intervention (after tDCS sessions 5 & 30)
measure: Change in Inhibition Ability
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Change in Conceptualization Ability
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Change in Picture Sequence Memory
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Change in Working Memory Ability
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Change in Processing Speed
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Cumulative Working Memory Performance Effects of HD-tDCS across daily sessions
timeFrame: Baseline Session through Session 6 then weekly up to final session
measure: Change in Global Cognition
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Change in Visuospatial Functioning
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Change in Language Functioning
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Change in Attention
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Change in Memory Functioning
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Change in Cognitive Functioning
timeFrame: Baseline and post-intervention (after tDCS sessions 5 & 30)
measure: Cumulative Cognitive Change across Daily Consecutive Sessions
timeFrame: After each HD-tDCS Session, daily
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Associate Professor
name: Benjamin Hampstead, PhD
role: PRINCIPAL_INVESTIGATOR
References: