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Completed

NCT Number: NCT04181658

The Brain Stimulation and Physical Therapy Study

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.

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Key information

Conditions

Fall Accidental Fall Aging Gait Disorders, Neurologic Gait, Unsteady Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hebrew Rehabilitation Center

Boston, Massachusetts, 02131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Real tDCS and Physical Therapy

Other

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.

Other names: Real tDCS + PT

Sham stimulation and Physical Therapy

Other

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.

Other names: Sham stimulation + PT

Primary outcomes

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

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

    The number of screenings needed to enroll one participant

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

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

    Number of tDCS sessions completed

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

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

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

  4. Side effects

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

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

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

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

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

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

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

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

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

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

    The change from baseline in cognitive executive function

Secondary outcomes

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

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

    The change from baseline in gait speed

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

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

    The change from baseline in gait speed

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

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

    The change from baseline in cognitive sustained attention

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

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

    The change from baseline in overall mobility function

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

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

    The change from baseline in global cognitive function

Sponsors and collaborators

Lead sponsor

Hebrew SeniorLife

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 29, 2019
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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