The Brain Stimulation and Physical Therapy Study

Hebrew SeniorLife10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fall Gait, Unsteady Aging Accidental Fall

Interventions

Real tDCS and Physical TherapyOTHER

The participant will receive 20-minute sessions of real tDCS before each physical therapy visit for up to 10 combined sessions, over approximately 6 weeks.

Sham stimulation and Physical TherapyOTHER

The participant will receive 20-minute sessions of sham stimulation before each physical therapy visit for up to 10 combined sessions, over approximately 6 weeks.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hebrew Rehabilitation Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Screening to enrollment ratio (%, 0-100, higher ratio means a better outcome)

The number of screenings needed to enroll one participant

Time frame: The whole data collection period (~ 6 months for the whole study)

Intervention adherence rate (%, 0-100, higher ratio means a better outcome)

Number of tDCS sessions completed

Time frame: The whole data collection period (~ 6 months for the whole study)

Adherence rate (%, 0-100, higher ratio means a better outcome)

The portion of enrolled participants who complete and adhere to the intervention who complete and adhere to the intervention

Time frame: The whole data collection period (~ 6 months for the whole study)

Side effects

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

Time frame: The whole data collection period (~ 6 months for the whole study)

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

The change from baseline in the degree to which performing a secondary cognitive task diminishes gait speed

Time frame: Before and after the intervention (~ 6 weeks per participant)

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

The change from baseline in the degree to which performing a secondary cognitive task diminishes the control of standing posture.

Time frame: Before and after the intervention (~ 6 weeks per participant)

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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

The change from baseline in gait speed

Time frame: Before and after the intervention (~ 6 weeks per participant)

Change from baseline in gait variability (reduced value after intervention means a better outcome)

The change from baseline in gait speed

Time frame: Before and after the intervention (~ 6 weeks per participant)

Change from baseline in gradual-onset continuous performance test (gradCPT) ( increased accuracy after intervention means a better outcome)

The change from baseline in cognitive sustained attention

Time frame: Before and after the intervention (~ 6 weeks per participant)

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

The change from baseline in overall mobility function

Time frame: Before and after the intervention (~ 6 weeks per participant)

Change from baseline in Montreal Cognitive Assessment (MoCA) total score (increased score after intervention means a better outcome)

The change from baseline in global cognitive function

Time frame: Before and after the intervention (~ 6 weeks per participant)