Elderly Idiopathic FallersNCT02954328
The Effect of Transcranial Direct Current Stimulation (tDCS) on Motor and Cognitive Functions in Idiopathic Fallers
A study testing tDCS in people with Elderly Idiopathic Fallers, run by Tel-Aviv Sourasky Medical Center at 2 sites in 2 countries.
Trial summary
The concurrent performance of two tasks, i.e., dual tasking (DT), is a common and ubiquitous every day phenomena. For example, people frequently walk while talking on a cellphone or drive while talking to a passenger. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly Idiopathic Fallers
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2016to Dec 2017
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 65-85 years,
- ability to walk for 6 minutes unassisted,
- adequate vision capabilities, and
- stable medications for the past month.
Who cannot join
- diagnosis of stroke, Parkinson's disease, peripheral neuropathy or other neurologic disorder,
- lower-extremity deformity, joint replacement, severe arthritis or other diagnosed musculoskeletal disorder that may influence gait,
- orthostatic hypotension, recent history of syncope or vertigo,
- myocardial infarction or surgery within the past 6 months,
- any unstable medical condition,
- psychiatric co-morbidity (e.g., major depressive disorder as determined by DSM V criteria),
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- likely dementia (i.e., Mini Mental State Exam score < 24 or based on DSM V),
- sedating medications (sedatives, anti-psychotics, hypnotics, anti-depressants,
- colorblindness (confounder for cognitive assessment), or
- contraindications to tDCS
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Hebrew Rehabilitation Center / Harvard Medical School
Roslindale, Massachusetts, 02121
Brad Manor, PhD, 617-632-8884, bradmanor@hsl.harvard.edu
Lewis Lipsitz, MD
Israel1 site, 1 recruiting
- Recruiting
Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Jeffrey Hausdorff, PhD, jhausdor@tasmc.health.gov.il
Talia Herman, MScPT, talit@tasmc.health.gov.il
About this study
The concurrent performance of two tasks, i.e., dual tasking (DT), is a common and ubiquitous every day phenomena. For example, people frequently walk while talking on a cellphone or drive while talking to a passenger. Often, the performance of one or more of these simultaneously performed tasks may deteriorate when another task is carried out at the same time, even in healthy young adults. This reduction in performance is referred to as the DT deficit or DT cost and is typically much higher in Idiopathic Fallers (IF) than in age-matched controls. In this population the DT cost impairs the gait pattern, as manifested, for example, in increased gait variability, exacerbating instability and fall risk.
In the proposed study, would be evaluated the effects of tDCS on dual tasking performance following tDCS.
The researchers expect that stimulation of the Pre Frontal Cortex (PFC) (using tDCS) will increase DT performance and prefrontal activation.
Read the detailed description
tDCS intervention: Noninvasive tDCS will be delivered by study personnel uninvolved with any other study procedures. In the study will be used a battery-driven electrical stimulator. Stimulation and sham condition will be performed based on previous studies. Briefly, the anode will be placed over the PFC and the cathode over the right supraorbital region. The real tDCS condition will consist of 20 min of continuous stimulation at target intensity of 1.5 mA. This amount of stimulation is safe for healthy young and older adults and has been shown to induce acute beneficial changes in cortical excitability and cognitive functions. For the sham condition, an inactive stimulation protocol would be followed, as compared with an 'off-target' active protocol, in order to minimize participant risk.
Pre- and post-tDCS assessments will include:
Gait assessment: Gait parameters will include both spatial and temporal parameters obtained using body fixed wearable sensors (accelerometers and gyroscopes) [Weiss et al. 2015; Ben et al. 2015]. Parameters will include (but are not limited to) gait speed, stride length and stride time as well as rhythmicity measures such as stride to stride variability and gait regularity.
Fall history and fear of falling will also be assessed (e.g., Falls Efficacy Scale International, FES-I) to further characterize the cohort and explore possible confounds.
Cognitive assessment: A detailed computerized cognitive battery that has been used extensively at TASMC in different cohorts [Dwolatzky et al. 2003;Hausdorff et al. 2006;Springer et al. 2006;Yogev et al. 2005;Aarsland et al. 2003] will quantify several cognitive domains including working memory, executive function, verbal function, problem solving, a global cognitive score, and attention.
- Conditions
- Elderly Idiopathic Fallers
- Being tested
- tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called Transcranial Direct Current Stimulation
The active tDCS condition will consist of 20 min of continuous stimulation. This amount of stimulation is safe for healthy young and older adults and has been shown to induce acute beneficial changes in cortical excitability and cognitive functions.
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Experimental | The active tDCS condition will consist of 4 visit:
During each visit, subject will receive a single 20-minute session targeting the prefrontal cortices of either real (1.5 mA) or sham tDCS. Total 4 different targets:
1. Sham
2. motor M1 area
3. motor M1 + Dorsolateral Prefrontal cortex
4. Dorsolateral Prefrontal cortex.
The tDCS condition will be randomized and double blinded Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate change in gait speed
Gait speed will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.
Measured: 1st measure will be taken at baseline ans 2nd immediate post intervention
Secondary outcomes (2)
fNIRS related frontal lobe activation - changes in tissue oxygenation
fNIRS will be used to investigate the role of the frontal lobe in DT walking and how it is affected by tDCS.The fNIR system provides with real-time monitoring of tissue oxygenation in the brain as subjects take different tests.
Measured: 1st measure will be taken at baseline ans 2nd immediate post intervention
Changes in cognitive performance - Executive Function composite score
The NeuroTrax software uses tests of cognitive performance that measure similar cognitive functions to traditional paper-based tests.
Measured: 1st measure will be taken at baseline ans 2nd immediate post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Elderly Idiopathic FallersStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Nir Giladi, Prof., Principal investigator, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954328
- Sponsor's protocol ID
- TASMC-16-NG-0699-CTIL
- Status last verified
- Apr 2017
- First submitted
- 31 Oct 2016
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zhou J, Hao Y, Wang Y, Jor'dan A, Pascual-Leone A, Zhang J, Fang J, Manor B. Transcranial direct current stimulation reduces the cost of performing a cognitive task on gait and postural control. Eur J Neurosci. 2014 Apr;39(8):1343-8. doi: 10.1111/ejn.12492. Epub 2014 Jan 20.
PubMed 24443958Schneider N, Dagan M, Katz R, Thumm PC, Brozgol M, Giladi N, Manor B, Mirelman A, Hausdorff JM. Combining transcranial direct current stimulation with a motor-cognitive task: the impact on dual-task walking costs in older adults. J Neuroeng Rehabil. 2021 Feb 1;18(1):23. doi: 10.1186/s12984-021-00826-2.
PubMed 33526043
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Direct Current Stimulation (tDCS) on Motor and Cognitive Functions in Idiopathic Fallers
- ClinicalTrials.gov ID
- NCT02954328
- Acronym / sponsor ID
- TASMC-16-NG-0699-CTIL
- Conditions
- Elderly Idiopathic Fallers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Nov 2016 (estimated)
- 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.
The concurrent performance of two tasks, i.e., dual tasking (DT), is a common and ubiquitous every day phenomena. For example, people frequently walk while talking on a cellphone or drive while talking to a passenger. Often, the performance of one or more of these simultaneously performed tasks may deteriorate when another task is carried out at the same time, even in healthy young adults. This reduction in performance is referred to as the DT deficit or DT cost and is typically much higher in Idiopathic Fallers (IF) than in age-matched controls. In this population the DT cost impairs the gait pattern, as manifested, for example, in increased gait variability, exacerbating instability and fall risk.
In the proposed study, would be evaluated the effects of tDCS on dual tasking performance following tDCS.
The researchers expect that stimulation of the Pre Frontal Cortex (PFC) (using tDCS) will increase DT performance and prefrontal activation.
Detailed description
tDCS intervention: Noninvasive tDCS will be delivered by study personnel uninvolved with any other study procedures. In the study will be used a battery-driven electrical stimulator. Stimulation and sham condition will be performed based on previous studies. Briefly, the anode will be placed over the PFC and the cathode over the right supraorbital region. The real tDCS condition will consist of 20 min of continuous stimulation at target intensity of 1.5 mA. This amount of stimulation is safe for healthy young and older adults and has been shown to induce acute beneficial changes in cortical excitability and cognitive functions. For the sham condition, an inactive stimulation protocol would be followed, as compared with an 'off-target' active protocol, in order to minimize participant risk.
Pre- and post-tDCS assessments will include:
Gait assessment: Gait parameters will include both spatial and temporal parameters obtained using body fixed wearable sensors (accelerometers and gyroscopes) [Weiss et al. 2015; Ben et al. 2015]. Parameters will include (but are not limited to) gait speed, stride length and stride time as well as rhythmicity measures such as stride to stride variability and gait regularity.
Fall history and fear of falling will also be assessed (e.g., Falls Efficacy Scale International, FES-I) to further characterize the cohort and explore possible confounds.
Cognitive assessment: A detailed computerized cognitive battery that has been used extensively at TASMC in different cohorts [Dwolatzky et al. 2003;Hausdorff et al. 2006;Springer et al. 2006;Yogev et al. 2005;Aarsland et al. 2003] will quantify several cognitive domains including working memory, executive function, verbal function, problem solving, a global cognitive score, and attention.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tDCS | Experimental | Device: tDCSThe active tDCS condition will consist of 4 visit: During each visit, subject will receive a single 20-minute session targeting the prefrontal cortices of either real (1.5 mA) or sham tDCS. Total 4 different targets: 1. Sham 2. motor M1 area 3. motor M1 + Dorsolateral Prefrontal cortex 4. Dorsolateral Prefrontal cortex. The tDCS condition will be randomized and double blinded |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- age 65-85 years,
- ability to walk for 6 minutes unassisted,
- adequate vision capabilities, and
- stable medications for the past month.
Key exclusion criteria (10 listed)
- diagnosis of stroke, Parkinson's disease, peripheral neuropathy or other neurologic disorder,
- lower-extremity deformity, joint replacement, severe arthritis or other diagnosed musculoskeletal disorder that may influence gait,
- orthostatic hypotension, recent history of syncope or vertigo,
- myocardial infarction or surgery within the past 6 months,
- any unstable medical condition,
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 |
|---|---|---|
| tDCSAlso: Transcranial Direct Current StimulationThe active tDCS condition will consist of 20 min of continuous stimulation. This amount of stimulation is safe for healthy young and older adults and has been shown to induce acute beneficial changes in cortical excitability and cognitive functions. | Device | tDCS |
Primary outcome
Immediate change in gait speed
Time frame: 1st measure will be taken at baseline ans 2nd immediate post intervention
Gait speed will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.
2 secondary outcomes
fNIRS related frontal lobe activation - changes in tissue oxygenation
Time frame: 1st measure will be taken at baseline ans 2nd immediate post intervention
Changes in cognitive performance - Executive Function composite score
Time frame: 1st measure will be taken at baseline ans 2nd immediate post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Results publication: PubMed 24443958Zhou J, Hao Y, Wang Y, Jor'dan A, Pascual-Leone A, Zhang J, Fang J, Manor B. Transcranial direct current stimulation reduces the cost of performing a cognitive task on gait and postural control. Eur J Neurosci. 2014 Apr;39(8):1343-8. doi: 10.1111/ejn.12492. Epub 2014 Jan 20.
- Derived from this study: PubMed 33526043Schneider N, Dagan M, Katz R, Thumm PC, Brozgol M, Giladi N, Manor B, Mirelman A, Hausdorff JM. Combining transcranial direct current stimulation with a motor-cognitive task: the impact on dual-task walking costs in older adults. J Neuroeng Rehabil. 2021 Feb 1;18(1):23. doi: 10.1186/s12984-021-00826-2.
- Individual participant dataSharing planned: No
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.
Nir Giladi, Prof. principal investigator
Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Elderly Idiopathic Fallers, run by Tel-Aviv Sourasky Medical Center at 2 sites in 2 countries.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey M Hausdorff, PhD (972-3-6974958, jhausdor@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate change in gait speed (time frame: 1st measure will be taken at baseline ans 2nd immediate post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02954328, which also lists 2 linked publications.
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 21 Apr 2017.