Personalized tDCS in Elderly Fallers Study

NCT03814304 | Completed DMC

• 1 other identifier: AG059089-01
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine if a four-week, 20-session intervention of personalized transcranial direct current stimulation (tDCS), as compared to sham intervention, improves dual task standing and walking performance (Aim 1), as well as other physical (Aim 2) and cognitive (Aim 3) factors on the causal pathway to falls, in older adults who report two or more falls within the past year and fear of falling again in the future, yet who do not have any acute or over neurological or musculoskeletal condition. Primary endpoints will include the "dual task" costs to gait speed when walking and postural sway speed when standing, as induced by performing a serial subtraction cognitive task (i.e., \[(speeddual task - speedsingle task) / speedsingle task) X 100\] (Aim 1), the Short Physical Performance Battery (Aim 2), and the Trail Making Test (Part B minus Part A) (AIM 3). Secondary endpoints will include the dual task cost to serial subtraction performance, additional gait and balance outcomes derived from the dual task paradigm, the Timed Up-and-Go, fear of falling, habitual physical activity, and performance within a battery of neuropsychological tests focused on global cognitive function, attention, verbal fluency and memory.

Conditions

Accidental Falls; Aging

Outcome Measures

Primary Outcomes (4)

• Change from baseline in the dual task cost to gait speed

  This metric will assess the change from baseline in the degree to which performing a secondary cognitive task diminishes gait speed.

  3-day follow-up; 3-month follow-up; 6-month follow-up

• Change from baseline in the dual task cost to standing postural sway speed

  This metric will assess the change from baseline in the degree to which performing a secondary cognitive task diminishes the control of standing posture.

  3-day follow-up; 3-month follow-up; 6-month follow-up

• Change from baseline in Short Physical Performance Battery (SPPB)

  This metric will assess the change from baseline in overall physical function.

  3-day follow-up; 3-month follow-up; 6-month follow-up

• Change from baseline in Montreal Cognitive Assessment (MoCA) total score

  This common test will assess the change from baseline in global cognitive function

  3-day follow-up; 3-month follow-up; 6-month follow-up

Secondary Outcomes (12)

• Change from baseline in the dual task cost to serial subtraction performance

  3-day follow-up; 3-month follow-up; 6-month follow-up

• Change from baseline in the dual task cost to stride time variability

  3-day follow-up; 3-month follow-up; 6-month follow-up

• Change from baseline in dual task cost to walking double support time

  3-day follow-up; 3-month follow-up; 6-month follow-up

• Change from baseline in the dual task cost to standing postural sway elliptical area

  3-day follow-up; 3-month follow-up; 6-month follow-up

• Change from baseline in Trail Making Test B - A

  3-day follow-up; 3-month follow-up; 6-month follow-up

Study Arms (2)

Personalized tDCS

EXPERIMENTAL

Personalized tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute 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 20, 20-minute sessions of personalized tDCS on Monday-Friday, at approximately the same time of day, over four consecutive weeks.

Personalized tDCS

Active-Sham OTHER

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

Active-Sham

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 60 or older
• Self-report of mobility and balance problems
• Self-report of fear of falling defined by a "yes" answer to the yes-or-no question "Is the participant worried about falling in the future?"
• Trail Making Test (TMT) Part B time below 75th percentile of age-and education-based norms
• A score of 10 or below on the Short Physical Performance Battery

You may not qualify if:

• Inability to stand or walk unassisted for 60 seconds
• Hospitalization within the past three months due to acute illness, or as the result of a musculoskeletal injury significantly affecting gait or balance
• Any unstable medical condition
• a diagnosis of a gait disorder, Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, previous stroke or other neurodegenerative disorder
• Chronic vertigo
• Myocardial infarction within the past 6 months
• Active cancer for which chemo-/radiation therapy is being received
• Psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
• Chronic use of any sedating medications (sedatives, anti-psychotics, hypnotics, anti-depressants) or change in medication within the previous month
• Legal blindness
• Contraindications to MRI or tDCS, including reported seizure within the past two years, use of neuro-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, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp
• A score below 22 on the Telephone Interview of Cognitive Status (TICS)
• Mild or severe dementia defined by a Clinical Dementia Rating (CDR) score of one or greater

Sponsors & Collaborators

• Hebrew SeniorLife: lead

Study Sites (1)

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131, United States

Location

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 such 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: PREVENTION
• 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 perform baseline functional assessments, as well as a structural MRI of the brain. They will then be assigned to a four-week, 20-session intervention of either personalized tDCS or sham (i.e., control) stimulation, via permuted block randomization stratified by sex to ensure that equal numbers of women, and equal numbers of men, are randomized to each arm.

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 24, 2019
• Study Start: July 8, 2019
• Primary Completion: January 24, 2025
• Study Completion: July 31, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

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)