Stimulation to Improve Memory

NCT03875326 | Completed Results DMC FDA Device

• 2 other identifiers: HUM001461801R01AG058724
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

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).

Conditions

Dementia of Alzheimer Type; Mild Cognitive Impairment

Keywords

Dementia; Memory; Cognitive Rehabilitation; PET scan; fMRI; Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Change in Lateral Temporal Cortex Connectivity

  Primary outcome focuses on default mode network (DMN) between-network functional connectivity because the lateral temporal cortex is a core component of the DMN. Between-network functional connectivity is estimated from fMRI data as strength of temporal coupling between the DMN and other high-level (association) brain networks. For each participant and time point, correlation-based connectivity (Pearson r; Fisher r-to-z transformed; arbitrary units) computed between DMN regions and other regions of the association cortex defined using standard functional atlas. Higher values reflect stronger functional connectivity between DMN and other regions. A Z-score's range is infinite. Expected value is between -3 to 3. Analyses conducted separately for amyloid negative (A-) and amyloid positive (A+) participants. Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

  Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

Secondary Outcomes (13)

• Self-Report of Contentment With Memory

  Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

• Self-Report of Memory Mistakes

  Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

• Self-Report of Memory Strategies Used

  Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

• Change in Memory Functioning

  Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

• Change in Overall Fluid Cognitive Abilities

  Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

Other Outcomes (10)

• Change in Inhibition Ability

  Baseline and post-intervention (after tDCS sessions 5 & 30)

• Change in Conceptualization Ability

  Baseline and post-intervention (after tDCS sessions 5 & 30)

• Change in Picture Sequence Memory

  Baseline and post-intervention (after tDCS sessions 5 & 30)

Study Arms (4)

Sham Stimulation

SHAM COMPARATOR

Sham (placebo) dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.

Device: Sham

1 mA Dosage Stimulation

EXPERIMENTAL

1 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.

Device: 1 mA HD-tDCS

2 mA Dosage Stimulation

EXPERIMENTAL

2 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.

Device: 2 mA HD-tDCS

3 mA Dosage Stimulation

EXPERIMENTAL

3 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.

Device: 3 mA HD-tDCS

Interventions

1 mA HD-tDCS DEVICE

Participants will receive HD-tDCS at 1 mA for 30 minutes, for between 5-30 sessions.

1 mA Dosage Stimulation

2 mA HD-tDCS DEVICE

Participants will receive HD-tDCS at 2 mA for 30 minutes, for between 5-30 sessions.

2 mA Dosage Stimulation

3 mA HD-tDCS DEVICE

Participants will receive HD-tDCS at 3 mA for 30 minutes, for between 5-30 sessions.

3 mA Dosage Stimulation

Sham DEVICE

Participants will receive sham (placebo) HD-tDCS for 30 minutes, for between 5-30 sessions.

Sham Stimulation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Mild Cognitive Impairment (MCI) or dementia of the Alzheimer's type (DAT)
• 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)
• Stable on relevant medications for at least 4 weeks prior to study enrollment

You may not qualify if:

• Certain neurological diseases
• Certain psychiatric conditions
• Severe sensory impairment

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Benjamin Hampstead
• Organization: University of Michigan

bhampste@med.umich.edu

734-936-6185

Study Officials

• Benjamin Hampstead, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stanley Berent, Ph.D., Collegiate Professor of Psychology

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 14, 2019
• Study Start: April 1, 2019
• Primary Completion: December 6, 2024
• Study Completion: December 19, 2024
• Last Updated: July 2, 2026
• Results First Posted: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)