Feasibility of Home-based tES for Older Adults at Risk of Falling

NCT04732533 | Active Not Recruiting

• 2 other identifiers: 2018-16Pro00044339
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

In this project, the investigators propose to demonstrate the feasibility of remotely-monitored, caregiver (or spouse)-administered, home-based tES (transcranial electrical stimulation) intervention to improve mobility in ambulatory older adults with recent falls. This is a four-phase feasibility study in older, ambulatory adult participants at risk of falling due to a loss of balance (participant faller, PF) together with a willing and able participant administrator (PA) that is available during weekdays to administer tES to the PF. Phase 1 is focused on the development and refinement of our training materials for home-based tDCS (transcranial direct current stimulation) for PF/PA pairs. The objectives of this phase:

1. 1.Identify areas of confusion and challenges for older adults.
2. 2.Refine our training materials to accompany the home-based tDCS system.
3. 3.Determine the mean/range number of visits needed for in-person training.
4. 4.Compliance and retention with the study protocol.
5. 5.Safety/side effects of home-based tES, as compared to previously established laboratory-based tES data.
6. 6.Further explore compliance and retention with the study protocol over a longer time period
7. 7.Identify safety/side effects of home-based tES over a longer time-period as compared to previously established laboratory-based tDCS interventions.
8. 8.Identify Safety, effectiveness and adherence to home-based tES over longer period of time as compared to previously established laboratory-based tES interventions.
9. 9.Further explore the proof of Concept for the home-based tES interventions

Conditions

Aging; Accidental Falls

Keywords

Mobility; Dual Task

Outcome Measures

Primary Outcomes (4)

• Screening to enrollment ratio ("percent", 0-100, higher ratio means a better outcome)

  The number of screenings needed to enroll one participant

  The whole data collection period of phase 2 (~ 6 weeks for the whole study)

• Intervention adherence rate ("percent", 0-100, higher ratio means a better outcome)

  Number of tDCS sessions completed

  The whole data collection period (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)

• Side effects

  The number, type, severity and duration of reported side effects

  The whole data collection period (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)

• Training sessions

  The number of training sessions needed for PAs to successfully and comfortably administer home-based tDCS

  The whole data collection period (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)

Secondary Outcomes (6)

• Change from baseline in the dual task cost to gait speed (reduced dual task cost after intervention means a better outcome)

  The whole data collection period (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)

• Change from baseline in the dual task cost to standing postural sway speed (reduced dual task cost after intervention means a better outcome)

  Before and after the intervention (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)

• Change from baseline in Trail Making Test B - A (reduced time after intervention means a better outcome)

  Before and after the intervention (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)

• Change from baseline in gait speed (increased value after intervention means a better outcome)

  Before and after the intervention (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)

• Change from baseline in Timed Up-and-Go (TUG) (reduced time after intervention means a better outcome)

  Before and after the intervention (~ 6 weeks for phase 2; ~ 52 weeks for phase 3; ~156 weeks for phase 4)

Study Arms (1)

tES (transcranial electrical stimulation)

EXPERIMENTAL

All participants in phase 1 received the tDCS (transcranial direct current stimulation) intervention. For each new potential participant recruited into Phase 2, 3 or 4, the type of tES intervention, either tDCS or a combination of tDCS and tACS (transcranial alternating current stimulation) will be determined at the discretion of the study PI in consultation with the participant. The tDCS intervention will be administered with the goal of facilitating the excitability of the left dlPFC (dorsolateral prefrontal cortex). The combination of tDCS and tACS intervention will be administered with the goals of 1) using tDCS to facilitate the excitability of the left dlPFC using the parameters outlined in the preceding paragraph, and at the same time, 2) using tACS targeting the left angular gyrus at gamma frequency 40 Hz.

Other: tES (transcranial electrical stimulation)

Interventions

tES (transcranial electrical stimulation) OTHER

Phase 1: The participant will receive 10, 20-minute sessions of tDCS on Monday-Friday, at approximately the same time of day, over two consecutive weeks. Phase 2: The participant will receive 22, 20-minute sessions of tES. 10 sessions will take place over the first two weeks on Monday-Friday, at approximately the same time of day. This will be followed by 3 tES sessions per week over four weeks. Phase 3: The participant will receive up to 260, 20-minute sessions of tES. The participant can complete up to 5 tDCS sessions per week over 52 weeks. Phase 4: The participant will receive up to 780, 20-minute sessions of tES. The participant can complete up to 5 tDCS sessions per week over 156 weeks.

tES (transcranial electrical stimulation)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PF group:
• Aged 60+
• Self-report of one or more falls within the past year, and/or concern of falling in the future, and/or self-report of Parkinson's disease.
• Able to read, write, and communicate in English
• Able to identify an eligible PA to participate with them in the study
• PA group:
• At least 21 years of age
• Able to read, write, and communicate in English
• Self-reported computer proficiency and willingness to learn how to use tDCS
• Stated availability during weekdays throughout the study period to administer tDCS to the PF

You may not qualify if:

• PF group:
• Evidence of cognitive impairment that would likely interfere with one's ability to understand the study protocol, risks/benefits, and testing procedures. This will be defined as self-reported diagnosis of Alzheimer's disease or dementia, a score of ≤19 on the Telephone Interview for Cognitive Status (TICS) at the time of telephone screening, a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen, or an inability to understand study procedures following review of the Informed Consent form.
• Inability to stand or ambulate unassisted for at least 25 feet.
• Contraindications to tDCS, including a reported seizure within the past two years, use of neuro-active drugs, the risk of metal objects in the brain, skull, or head, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant), or the presence of any active, uncontrolled dermatological condition, such as eczema, on the scalp.
• PA group:
• Mild cognitive impairment defined by a TICS score ≤34 during the phone screen, a MoCA score ≤24 during the in-person screen, or insufficient understanding of study procedures following review of the Informed Consent form.
• Poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tDCS.

Sponsors & Collaborators

• Hebrew SeniorLife: lead

Study Sites (1)

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131, United States

Location

MeSH Terms

Interventions

TES; Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Brad Manor, PhD

  Hebrew SeniorLife

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group, open-label intervention.

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 1, 2021
• Study Start: January 25, 2021
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 23, 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)