The Brain Stimulation and Physical Therapy Study

Aging Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04181658
• Other study ID #: IRB-2019-24
• Status: Completed
• Phase: N/A
• Start date: October 22, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: September 2021
• Source: Hebrew SeniorLife
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Accidental Fall
• Aging
• Fall
• Gait Disorders, Neurologic
• Gait, Unsteady

Intervention

Other:
• Real tDCS and Physical Therapy
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 Therapy
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.

Locations

Country	Name	City	State
United States	Hebrew Rehabilitation Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Hebrew SeniorLife

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening to enrollment ratio (%, 0-100, higher ratio means a better outcome)	The number of screenings needed to enroll one participant	The whole data collection period (~ 6 months for the whole study)
Primary	Intervention adherence rate (%, 0-100, higher ratio means a better outcome)	Number of tDCS sessions completed	The whole data collection period (~ 6 months for the whole study)
Primary	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	The whole data collection period (~ 6 months for the whole study)
Primary	Side effects	The number, type, severity and duration of reported side effects	The whole data collection period (~ 6 months for the whole study)
Primary	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	Before and after the intervention (~ 6 weeks per participant)
Primary	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.	Before and after the intervention (~ 6 weeks per participant)
Primary	Change from baseline in Trail Making Test B - A (reduced time after intervention means a better outcome)	The change from baseline in cognitive executive function	Before and after the intervention (~ 6 weeks per participant)
Secondary	Change from baseline in gait speed (increased value after intervention means a better outcome)	The change from baseline in gait speed	Before and after the intervention (~ 6 weeks per participant)
Secondary	Change from baseline in gait variability (reduced value after intervention means a better outcome)	The change from baseline in gait speed	Before and after the intervention (~ 6 weeks per participant)
Secondary	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	Before and after the intervention (~ 6 weeks per participant)
Secondary	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	Before and after the intervention (~ 6 weeks per participant)
Secondary	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	Before and after the intervention (~ 6 weeks per participant)