The Effect of Transcranial Direct Current Stimulation (tDCS) on Motor and Cognitive Functions in Idiopathic Fallers

NCT02954328 | Unknown

• 1 other identifier: TASMC-16-NG-0699-CTIL
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

Brief 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. 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.

Conditions

Elderly Idiopathic Fallers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• fNIRS related frontal lobe activation - changes in tissue oxygenation

  1st measure will be taken at baseline ans 2nd immediate post intervention

• Changes in cognitive performance - Executive Function composite score

  1st measure will be taken at baseline ans 2nd immediate post intervention

Study Arms (1)

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

Device: tDCS

Interventions

tDCS DEVICE

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.

Also known as: Transcranial Direct Current Stimulation

tDCS

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• age 65-85 years,
• ability to walk for 6 minutes unassisted,
• adequate vision capabilities, and
• stable medications for the past month.

You may not qualify if:

• 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),
• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (2)

Hebrew Rehabilitation Center / Harvard Medical School

Roslindale, Massachusetts, 02121, United States

RECRUITING

Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Related Publications (2)

• 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.

  PMID: 24443958 RESULT

• Schneider 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.

  PMID: 33526043 DERIVED

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Nir Giladi, Prof.

  Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey M Hausdorff, PhD

CONTACT

972-3-6974958; jhausdor@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Development

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 3, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (1)