Personalized tDCS for Falls, Accidental

Phase-Based Estimates
1
Effectiveness
1
Safety
Hebrew Rehabilitation Center, Roslindale, MA
+1 More
Personalized tDCS - Other
Eligibility
18+
All Sexes
Eligible conditions
Falls, Accidental

Study Summary

Personalized tDCS in Elderly Fallers Study

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Eligible Conditions

  • Falls, Accidental
  • Aging

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Personalized tDCS will improve 4 primary outcomes and 12 secondary outcomes in patients with Falls, Accidental. Measurement will happen over the course of 3-day follow-up; 3-month follow-up; 6-month follow-up.

3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in 5-day accelerometry-based habitual physical activity
Change from baseline in Category and Phonemic Fluency Test
Change from baseline in Digit Span
Change from baseline in Falls Efficacy Scale
Change from baseline in Hopkins Verbal Learning Test
Change from baseline in Montreal Cognitive Assessment (MoCA) total score
Change from baseline in Short Physical Performance Battery (SPPB)
Change from baseline in Timed Up-and-Go (TUG)
Change from baseline in Trail Making Test B - A
Change from baseline in WAIS-IV Coding Test
Change from baseline in dual task cost to walking double support time
Change from baseline in the dual task cost to gait speed
Change from baseline in the dual task cost to serial subtraction performance
Change from baseline in the dual task cost to standing postural sway elliptical area
Change from baseline in the dual task cost to standing postural sway speed
Change from baseline in the dual task cost to stride time variability

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Active-Sham
Personalized tDCS
Placebo group

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Personalized TDCS is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Personalized tDCS
Other
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.
Active-Sham
Other
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3-day follow-up; 3-month follow-up; 6-month follow-up
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3-day follow-up; 3-month follow-up; 6-month follow-up for reporting.

Who is running the study

Principal Investigator
B. M.
Brad Manor, Assistant Scientist II; Director, Mobility and Brain Function Lab, Hinda and Arthur Marcus Institute for Aging Research
Hebrew SeniorLife

Closest Location

Hebrew Rehabilitation Center - Roslindale, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A score of 10 or below on the Short Physical Performance Battery
Trail Making Test (TMT) Part B time below 75th percentile of age-and education-based norms
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?"

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes falls, accidental?

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Falls, accidental falling was the most common cause reported. Older adults who live alone were most likely to fall, thus increasing the burden on the health care system.

Unverified Answer

How serious can falls, accidental be?

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Those who had a history of fall injuries were more likely to fall again than those who did not. They have a greater likelihood of sustaining injuries that might affect health-related quality of life (e.g., hip fracture, shoulder injury).

Unverified Answer

How many people get falls, accidental a year in the United States?

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We estimate the incidence of falls (and related injuries) can range from 3.37 to 7.41 falls a year/person depending on the criteria of falls, and 3.13 to 8.36 falls per person in the population age 65 and older.

Unverified Answer

What are the signs of falls, accidental?

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There is a lack of evidence regarding the accuracy of falling risk identification and assessment. This discrepancy has been identified as a major issue in the identification and management of falls and accidents. There is an urgent need for more accurate information to facilitate the identification, assessment, management and prevention of falls.

Unverified Answer

Can falls, accidental be cured?

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Results from a recent clinical trial suggests that falls, accidental may be more easily manageable by patients as compared to serious falls, intentional. This may be due to more effective fall prevention strategies for accidental falls and fall-prone subjects.

Unverified Answer

What are common treatments for falls, accidental?

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Common interventions for falls, accidental include physical therapy, orthotic aids and exercise training, as opposed to medication. There are no evidence based recommendations for either exercise or medication for falls treatment, therefore, the use of these interventions should be done on a case by case basis.

Unverified Answer

What is falls, accidental?

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Falls, accidental is the commonest cause of admission to the emergency department and hospital amongst older people. Older people are not as well protected against falls, accidental as younger people may be.

Unverified Answer

How does personalized tdcs work?

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Results demonstrate that subjects with mild to severe gait disorders show larger reductions in pain by using the customized tDCS device and show no significant change in gait speed or balance. Additionally, no change in gait speed is seen in healthy participants using tDCS.

Unverified Answer

What is the latest research for falls, accidental?

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The literature survey shows that falls, accidental injuries in the elderly, are a multi-factorial problem which is still not completely understood. The medical literature contains a number of research reports which emphasize the risks of falls and accidental accidents.

Unverified Answer

What is personalized tdcs?

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Findings from a recent study shows that anodal transcranial direct current stimulation to left anodal F5 and right anodal F1/2, tDCS to posterior parietal cortex, reduces risk of balance, mobility and functional disability in older people with a history of accidental falls. Findings from a recent study should aid decision support and prioritization of clinical research into tDCS for fall prevention. [International Standard Randomized Controlled Trial Number: ISRCTN-14449912.

Unverified Answer

Does falls, accidental run in families?

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The authors suggest that a prospective and multicenter study be conducted to evaluate the predisposing risk factors with other possible risk assessments for the development of FES of different types and the course of fall in fallers.

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What are the common side effects of personalized tdcs?

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Subjects exhibited subjective and behavioural changes in a variety of domains that were not predicted by baseline measures, supporting the hypothesis that the effects of 'deep' tDCS are specific to the site of stimulation.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Falls, Accidental by sharing your contact details with the study coordinator.