The Brain Stimulation and Physical Therapy Study

NCT04181658 | Completed

• 1 other identifier: IRB-2019-24
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall; Gait, Unsteady; Aging; Accidental Fall

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• Side effects

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

  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

  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.

  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)

  The change from baseline in cognitive executive function

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

Secondary Outcomes (5)

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

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

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

  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)

  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)

  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)

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

Study Arms (2)

Real tDCS and Physical Therapy

EXPERIMENTAL

This arm combines tDCS and Physical Therapy intervention. The real tDCS will be delivered before each physical therapy visit for up to 10 combined sessions. The tDCS montage was designed to target the left dorsal lateral prefrontal cortex (DLPFC) for around 20 minutes. The direct current delivered by any electrode will not exceed 2.0 milliamp(mA) and the total amount of current from all electrodes will not exceed 4 mA.

Other: Real tDCS and Physical Therapy

Sham stimulation and Physical Therapy

SHAM COMPARATOR

This arm combines sham stimulation and Physical Therapy intervention. The sham stimulation will be delivered before each physical therapy visit for up to 10 combined sessions. We will use an active sham stimulation 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 montage was designed to deliver currents not significantly influence their cortical tissue, but still, mimic the cutaneous sensations induced by tDCS over the same brain site (i.e. left DLPFC).

Other: Sham stimulation and Physical Therapy

Interventions

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.

Also known as: Real tDCS + PT

Real tDCS and Physical Therapy

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.

Also known as: Sham stimulation + PT

Sham stimulation and Physical Therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebrew SeniorLife: lead

Study Sites (1)

Hebrew Rehabilitation Center

Boston, Massachusetts, 02131, United States

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• On-Yee Lo, PhD

  Hebrew Rehabilitation Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: November 29, 2019
• Study Start: October 22, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

US (1)