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

Aging Clinical Trial

Official title: Feasibility of Home-based tDCS for Older Adults at Risk of Falling

Status Recruiting

Clinical Trial Summary

In this project, the investigators propose to demonstrate the feasibility of remotely-monitored, caregiver (or spouse)-administered, home-based tDCS intervention to improve mobility in ambulatory older adults with recent falls. This is a three-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 tDCS (transcranial direct current stimulation) to the PF.

Phase 1 is focused on the development and refinement of our training materials for home-based tDCS for PF/PA pairs. The objectives of this phase:

1. Identify areas of confusion and challenges for older adults.

2. Refine our training materials to accompany the home-based tDCS system.

In Phase 2, the investigators will complete a pilot trial in 12 PF/PA pairs to assess the feasibility of deploying home-based tDCS in larger clinical trials, and to prepare for the development and implementation of such trials. The objectives of this phase:

1. Determine the mean/range number of visits needed for in-person training.

2. Compliance and retention with the study protocol.

3. Safety/side effects of home-based tDCS, as compared to previously established laboratory-based tDCS data.

The investigators hypothesize that adult PAs are able to successfully administer home-based tDCS to PFs. The investigators also expect that PF/PA pairs will exhibit excellent adherence to the intervention and that the prevalence and severity of reported tDCS side-effects will be similar to that observed in previous laboratory-based studies.

In Phase 3, the investigators will complete a pilot trial in up to 18 PF/PA pairs; i.e., those who have previously successfully completed either Phase 1 or Phase 2. The study objectives/aims for Phase 3 are:

1. Further explore compliance and retention with the study protocol over a longer time period

2. Identify safety/side effects of home-based tDCS over a longer time-period as compared to previously established laboratory-based tDCS interventions.

In Phase 3, the investigators hypothesize that adult PA's who have previously demonstrated the ability to successfully administer tDCS at home, will retain competence and compliance with administration over a longer period, up to 1 year.

Clinical Trial Description

In older adults, falls are costly, consequential and correlated with both physical and cognitive decline. Most falls occur when standing or walking, especially when completing these tasks in complex environments or while simultaneously performing additional cognitive tasks. To this end, older adults with worse cognitive "executive" function have worse mobility and are more likely to fall.

tDCS (transcranial Direct Current Stimulation) holds promise as a therapy to improve dual task standing and walking and other "high-level" aspects of mobility in older adults. tDCS is a low cost technique, is very safe with only minimal side effects, is portable and is very easy to administer. However, tDCS must be administered numerous times per week for several consecutive weeks in order to induce lasting therapeutic benefit. As each tDCS session must currently be administered in clinical or laboratory settings, such interventions are not currently available to many older adults--especially those who 1) live far away from the clinical/laboratory, and/or 2) have physical and/or cognitive limitations that make it difficult to organize and utilize transportation.

In this project, the investigators propose to demonstrate the feasibility of remotely-monitored, caregiver (or spouse)-administered, home-based tDCS intervention to improve mobility in ambulatory older adults with recent falls. The investigators will do so by completing a three-phase feasibility study in ambulatory older adults at risk of falling due to loss of balance, together with an identified caregiver, using commercially-available tDCS equipment designed for home use. The investigators will utilize a tDCS system called the Starstim Home Kit® (Neuroelectrics Corp). The Starstim Home Kit enables researchers and clinicians to "prescribe" home-based tDCS to end users. Following in-person training sessions, users take home a pre-configured and personalized Starstim system. Phase 1 will involve development of home-based tDCS training materials designed for older adults. Phase 2 will consist of a small, pilot trial to determine numerous factors needed to design a larger, well-controlled trial of home-based tDCS within this population. Phase 3 will further explore feasibility of home-based tDCS, including compliance and retention with the study protocol over a longer time-period. ;

Related Conditions & MeSH terms

• Accidental Falls
• Aging

• NCT number: NCT04732533
• Study type: Interventional
• Source: Hebrew SeniorLife
• Contact: Peggy Gagnon
• Phone: 617-971-5303
• Email: Gagnon@hsl.harvard.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2021
• Completion date: January 24, 2026