Clinical trial NCT04181658: The Brain Stimulation and Physical Therapy Study
Official title: The Feasibility and Effectiveness of Combining Non-invasive Brain Stimulation and Physical Therapy to Improve Gait and Balance in Older Adults at Risk of Falling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Gait, Unsteady
Aging
Accidental Fall
Lead sponsor: Hebrew SeniorLife
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot work will determine the feasibility of tDCS intervention as an effective adjunct intervention to PT aimed at improving gait, balance, and mobility in older adults at risk of falling.

Detailed description: Falls are correlated with both physical and cognitive declines in older adults. Recurrent fallers and those at high risk of falls are often referred to physical therapy (PT) for gait and balance training. Although physical therapists are aware of the importance of cortical control of gait and balance, there is no available tool to directly yet non-invasively intervene brain in the clinical setting.

Transcranial direct current stimulation (tDCS) is a noninvasive and safe mean of modulating the excitability of specific brain regions and their connected neural networks. Our group and others have shown that tDCS intervention designed to facilitate the excitability of the left dorsal lateral prefrontal cortex (DLPFC) improves numerous aspects of executive function related to mobility in older adults. However, no studies to date have assessed the feasibility and effectiveness of applying tDCS as an adjunct to PT to improve gait and balance within the geriatric rehabilitation setting.

This study aims to 1) assess the feasibility of implementing tDCS prior to each of their first 10 PT sessions, and 2) gather estimates of variability in outcomes related to gait, balance, cognition, and quality of life over time within older adults referred to PT for recurrent falls.

Eligibility criteria: Inclusion Criteria:

* Ages 65 years old and above
* Admitted to Physical Therapy for gait and balance training due to the high risk of falls

Exclusion Criteria:

* Inability to stand or walk unassisted for 60 seconds
* Severe cognitive impairment defined as a Montreal Cognitive Assessment (MoCA) score \< 18
* Any unstable medical condition
* Any unstable psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
* Active cancer for which chemo/radiation therapy id being received
* Significant vision and hearing problems that cannot be corrected with visual and hearing aids
* Contraindications to tDCS, including seizure within the past two years, use of neuro-active drugs, the risk of metal objects in the brain, implanted medical devices, or the presence of dermatological conditions such as eczema on the scalp.

Primary outcomes:
measure: Screening to enrollment ratio (%, 0-100, higher ratio means a better outcome)
timeFrame: The whole data collection period (~ 6 months for the whole study)
measure: Intervention adherence rate (%, 0-100, higher ratio means a better outcome)
timeFrame: The whole data collection period (~ 6 months for the whole study)
measure: Adherence rate (%, 0-100, higher ratio means a better outcome)
timeFrame: The whole data collection period (~ 6 months for the whole study)
measure: Side effects
timeFrame: The whole data collection period (~ 6 months for the whole study)
measure: Change from baseline in the dual task cost to gait speed (reduced dual task cost after intervention means a better outcome)
timeFrame: Before and after the intervention (~ 6 weeks per participant)
measure: Change from baseline in the dual task cost to standing postural sway speed (reduced dual task cost after intervention means a better outcome)
timeFrame: Before and after the intervention (~ 6 weeks per participant)
measure: Change from baseline in Trail Making Test B - A (reduced time after intervention means a better outcome)
timeFrame: Before and after the intervention (~ 6 weeks per participant)
Secondary outcomes:
measure: Change from baseline in gait speed (increased value after intervention means a better outcome)
timeFrame: Before and after the intervention (~ 6 weeks per participant)
measure: Change from baseline in gait variability (reduced value after intervention means a better outcome)
timeFrame: Before and after the intervention (~ 6 weeks per participant)
measure: Change from baseline in gradual-onset continuous performance test (gradCPT) ( increased accuracy after intervention means a better outcome)
timeFrame: Before and after the intervention (~ 6 weeks per participant)
measure: Change from baseline in Timed Up-and-Go (TUG) (reduced time after intervention means a better outcome)
timeFrame: Before and after the intervention (~ 6 weeks per participant)
measure: Change from baseline in Montreal Cognitive Assessment (MoCA) total score (increased score after intervention means a better outcome)
timeFrame: Before and after the intervention (~ 6 weeks per participant)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Hebrew Rehabilitation Center
state: Massachusetts
Study officials:
affiliation: Hebrew Rehabilitation Center
name: On-Yee Lo, PhD
role: PRINCIPAL_INVESTIGATOR
References: