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

Launched by HEBREW SENIORLIFE · Jan 27, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help older adults who have experienced falls by using a method called home-based tDCS, which stands for transcranial direct current stimulation. This is a safe and non-invasive technique that uses low electrical currents to stimulate the brain. The study involves pairs of participants: one older adult who is at risk of falling and a caregiver or spouse who will help administer the treatment at home. The main goal is to see if this approach can improve mobility and balance, making it easier for older adults to move around safely.

To participate, older adults must be at least 60 years old, have had a fall in the past year, or be concerned about falling. They also need to be able to read and communicate in English and have someone who can help them with the study. The caregiver must be at least 21 years old and comfortable using a computer. Participants can expect to receive training and support during the study, which will be conducted in three phases to ensure everything runs smoothly and safely. The researchers are committed to making this treatment as accessible as possible for older adults, and they will be monitoring safety and any side effects closely.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Inclusion criteria will be the same for PF/PA pairs in both Phase 1 and Phase 2 of the study. All participant pairs who complete either Phase 1 or 2 will be eligible to complete Phase 3. All participant teams who complete Phase 3 in its entirety will be eligible to complete Phase 4
• 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
• Exclusion Criteria:
• • Exclusion criteria will be the same for PF/PA pairs in both Phase 1 and Phase 2 of the study.
• 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.