Elderly Idiopathic Fallers Clinical Trial
Official title:
The Effect of Transcranial Direct Current Stimulation (tDCS) on Motor and Cognitive Functions in Idiopathic Fallers
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 65 Years to 85 Years |
| Eligibility |
Inclusion Criteria: 1. age 65-85 years, 2. ability to walk for 6 minutes unassisted, 3. adequate vision capabilities, and 4. stable medications for the past month. Exclusion Criteria: 1. diagnosis of stroke, Parkinson's disease, peripheral neuropathy or other neurologic disorder, 2. lower-extremity deformity, joint replacement, severe arthritis or other diagnosed musculoskeletal disorder that may influence gait, 3. orthostatic hypotension, recent history of syncope or vertigo, 4. myocardial infarction or surgery within the past 6 months, 5. any unstable medical condition, 6. psychiatric co-morbidity (e.g., major depressive disorder as determined by DSM V criteria), 7. likely dementia (i.e., Mini Mental State Exam score < 24 or based on DSM V), 8. sedating medications (sedatives, anti-psychotics, hypnotics, anti-depressants, 9. colorblindness (confounder for cognitive assessment), or 10. contraindications to tDCS |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center | Tel Aviv | |
| United States | Hebrew Rehabilitation Center / Harvard Medical School | Roslindale | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Tel-Aviv Sourasky Medical Center |
United States, Israel,
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.1249 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 1st measure will be taken at baseline ans 2nd immediate post intervention | |
| Secondary | 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. | 1st measure will be taken at baseline ans 2nd immediate post intervention | |
| Secondary | 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. | 1st measure will be taken at baseline ans 2nd immediate post intervention |