Individualized Brain Stimulation to Improve Mobility in Alzheimer's Disease

NCT04289402 | Active Not Recruiting

• 1 other identifier: 3P30AG031679-09S1
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to conduct a pilot, randomized sham-controlled trials to determine the feasibility and effects of a 10-session personalized tDCS intervention targeting the left dorsolateral prefrontal cortex on cognitive function, dual task standing and walking, and other metrics of mobility in 24 older adults with mild AD living in supportive housing.

Conditions

Aging; Alzheimer Dementia; Presenile Alzheimer Dementia

Keywords

Aging

Outcome Measures

Primary Outcomes (6)

• Recruitment efficiency

  The number of residents that need to be screened in order to enroll one participant into the trial.

  1 year

• Retention

  The percentage of enrolled participants who complete the trial.

  1 year

• Blinding

  A blinding efficacy questionnaire will be used to record participant guesses of their assigned intervention (real or placebo), as well as the confidence of these guesses on a scale from 1=Not confident to 10=Extremely confident.

  Immediately after intervention

• Montreal Cognitive Assessment (MoCA) total score

  This common test assesses global cognitive function. Maximum score on the MoCA is 30 points (minimum = 0), with higher scores associated with better outcomes.

  Change from baseline to two-week follow-up

• Dual task gait speed

  This metric assesses the ability to control gait while performing a secondary cognitive task.

  Change from baseline to two-week follow-up

• Dual task standing postural sway area

  This metric assesses the ability to control standing posture while performing a secondary cognitive task.

  Change from baseline to two-week follow-up

Secondary Outcomes (10)

• Trail making test A-B

  Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention

• Digit Span

  Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention

• Digit Symbol Substitution Test

  Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention

• Category and Phonemic Fluency Test

  Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention

• Hopkins Verbal Learning Test

  Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention

Study Arms (2)

Personalized tDCS

EXPERIMENTAL

Baseline MRIs will enable personalization of tDCS via current flow modeling for optimization to each participant with the goal of generating an average electric field of 0.25 V/m within their identified left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA and the total amount of current from all electrodes will not exceed 4 mA. Each 20-minutes session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.

Other: Personalized tDCS

Active-Sham

SHAM COMPARATOR

The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.

Other: Active-Sham

Interventions

Personalized tDCS OTHER

The participant will receive 10, 20-minutes sessions of personalized tDCS Monday-Friday, at approximately the same time of day, over two consecutive weeks.

Personalized tDCS

Active-Sham OTHER

The participant will receive 20, 20-minute sessions of active-sham stimulation Monday-Friday, at approximately the same time of day, over two consecutive weeks.

Active-Sham

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Men and women aged 65 and older living within supportive housing facilities
• Mild Alzheimer's disease (AD) defined by the combination of 1) at least mild cognitive impairment defined as a modified TICS score of ≤ 34, 2) informant-report of Instrumental Activities of Daily Living impairment as defined as a score of ≥ 6 on the NACC Functional Activities Questionnaire, and 3) a Clinical Dementia Rating score of 1.

You may not qualify if:

• Inability to secure informant participation
• Unwillingness to cooperate or participate in the study protocol
• An inability to ambulate without the assistance of another person (canes or walkers allowed)
• A clinical history of stroke, Parkinson's disease or parkinsonian symptoms, multiple sclerosis, normal pressure hydrocephalus, or other neurological conditions outside of mild AD.
• Any report of severe lower-extremity arthritis or physician-diagnosis of peripheral neuropathy
• Use of antipsychotics, anti-seizure, benzodiazepines, or other neuroactive medications
• Severe depression defined by a Center for Epidemiologic Studies Depression scale score greater than 16
• Any report of physician-diagnosis of schizophrenia, bipolar disorder, or other psychiatric illness
• Contraindications to MRI or tDCS, including reported seizure within the past two years, use of neuropsychological-active drugs, the risk of metal objects anywhere in the body, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemakers, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp

Sponsors & Collaborators

• Hebrew SeniorLife: lead

Study Sites (1)

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Brad Manor, PhD

  Hebrew SeniorLife

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study personnel administering tDCS and the participants will not be aware of tDCS intervention arm assignment. The investigators will ensure double-blinding by programming the tDCS software with intervention-specific stimulation codes, as supplied by personnel uninvolved in data collection prior to study initiation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Scientist II; Director, Mobility and Brain Function Lab, Hinda and Arthur Marcus Institute for Aging Research

Model Details: The investigators will conduct a single site, sham-controlled, double-blinded, randomized trial of tDCS. Participants will complete baseline cognitive and physical functioning assessments, as well as a structural MRI of the brain. They will then be assigned to a two-week, 10-session intervention of either personalized tDCS sham (i.e., control) stimulation, via permuted block randomization stratified by sex to ensure that equal number of men and women are randomized to each intervention arm.

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 28, 2020
• Study Start: January 31, 2020
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The investigators will make the data and associated documentation available once summary data are published or otherwise made available, starting six months after publication.
• Access Criteria: The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: 1) a commitment to using data only for research purposes and not to identify any particular participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed. The availability of data will be advertised over the Internet through websites maintained by Hebrew SeniorLife and Harvard Medical School. All investigators wishing to access the data will submit a brief proposal describing their research project, data needs, regulatory approvals, and mechanisms to assure patient confidentiality. Upon affirmative review by the Principal Investigator and co-investigators of this study, a data-sharing agreement will be signed and the requesting investigators will be given a working data file and appropriate documentation.

Locations

US (1)