FallNCT04181658
The Brain Stimulation and Physical Therapy Study
A study testing Real tDCS and Physical Therapy in people with Fall and Gait, Unsteady, run by Hebrew SeniorLife at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall, Gait, Unsteady, Aging
- What is being tested?
- Real tDCS and Physical Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2019to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Ages 65 years old and above
- Admitted to Physical Therapy for gait and balance training due to the high risk of falls
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hebrew Rehabilitation Center
Boston, Massachusetts, 02131
About this study
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
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.
Read the 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.
- Conditions
- Fall, Gait, Unsteady, Aging, Accidental Fall
- Being tested
- Real tDCS and Physical Therapy, Sham stimulation and Physical Therapy
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real tDCS and Physical TherapyOther
Also called Real tDCS + PT
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
Also called Sham stimulation + PT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Sham stimulation and Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening to enrollment ratio (%, 0-100, higher ratio means a better outcome)
The number of screenings needed to enroll one participant
Measured: 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
Measured: 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
Measured: The whole data collection period (~ 6 months for the whole study)
Side effects
The number, type, severity and duration of reported side effects
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
The change from baseline in gait speed
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Before and after the intervention (~ 6 weeks per participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start22 Oct 2019
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- On-Yee Lo, PhD, Principal investigator, Hebrew Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181658
- Sponsor's protocol ID
- IRB-2019-24
- Status last verified
- Sep 2021
- First submitted
- 26 Nov 2019
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04181658
- Acronym / sponsor ID
- IRB-2019-24
- Conditions
- Fall, Gait, Unsteady, Aging, Accidental Fall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real tDCS and Physical Therapy | Experimental | Other: Real tDCS and Physical TherapyThis 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. |
| Sham stimulation and Physical Therapy | Sham comparator | Other: Sham stimulation and Physical TherapyThis 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Ages 65 years old and above
- Admitted to Physical Therapy for gait and balance training due to the high risk of falls
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real tDCS and Physical TherapyAlso: Real tDCS + PTThe 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 | Real tDCS and Physical Therapy |
| Sham stimulation and Physical TherapyAlso: Sham stimulation + PTThe 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 | Sham stimulation and Physical Therapy |
Primary outcome
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
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
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
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
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
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.
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
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
On-Yee Lo, PhD principal investigator
Hebrew Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real tDCS and Physical Therapy in people with Fall and Gait, Unsteady, run by Hebrew SeniorLife at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.