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The Brain Stimulation and Physical Therapy Study

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ClinicalTrials.gov Identifier: NCT04181658
Recruitment Status : Recruiting
First Posted : November 28, 2019
Last Update Posted : November 28, 2019
Sponsor:
Information provided by (Responsible Party):
Hebrew Rehabilitation Center, Boston

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.

Condition or disease Intervention/treatment Phase
Fall Gait, Unsteady Aging Accidental Fall Other: Real tDCS and Physical Therapy Other: Sham stimulation and Physical Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 22, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Real tDCS and Physical Therapy
The tDCS montage was designed to target the left dorsal lateral prefrontal cortex (DLPFC). The direct current delivered by any electrode will not exceed 2.0 milliamp(mA); the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp-up/down of current amplitude to maximize comfort.
Other: Real tDCS and Physical Therapy
The participant will receive 10, 20-minute sessions of real tDCS on the same day as one's physical therapy session (either before or after each physical therapy visit) over approximately 6 weeks.
Other Name: Real tDCS + PT

Sham Comparator: Sham stimulation and Physical Therapy
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
The participant will receive 10, 20-minute sessions of sham stimulation on the same day as one's physical therapy session (either before or after each physical therapy visit) over approximately 6 weeks.
Other Name: Sham stimulation + PT




Primary Outcome Measures :
  1. Screening to enrollment ratio [ 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 [ Time Frame: The whole data collection period (~ 6 months for the whole study) ]
    Number of tDCS sessions completed

  3. Adherence rates [ 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 [ 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 [ 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 [ Time Frame: Before and after the intervention (~ 6 weeks per participant) ]
    The change from baseline in cognitive executive function


Secondary Outcome Measures :
  1. Change from baseline in gait speed [ 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 [ 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) [ 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) [ 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 [ Time Frame: Before and after the intervention (~ 6 weeks per participant) ]
    The change from baseline in global cognitive function



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04181658


Contacts
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Contact: Ted Gruen, PhD 617-931-5334 gruen@hsl.harvard.edu
Contact: Kathryn Tasker 617-971-5351 KathyTasker@hsl.harvard.edu

Locations
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United States, Massachusetts
Hebrew Rehabilitation Center Recruiting
Boston, Massachusetts, United States, 02131
Contact: On-Yee Lo, Ph.D.    617-931-5331    AmyLo@hsl.harvard.edu   
Principal Investigator: On-Yee Lo, PhD         
Sponsors and Collaborators
Hebrew Rehabilitation Center, Boston
Investigators
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Principal Investigator: On-Yee Lo, PhD Hebrew Rehabilitation Center

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Responsible Party: Hebrew Rehabilitation Center, Boston
ClinicalTrials.gov Identifier: NCT04181658     History of Changes
Other Study ID Numbers: IRB-2019-24
First Posted: November 28, 2019    Key Record Dates
Last Update Posted: November 28, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gait Disorders, Neurologic
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms