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

NCT ID: NCT02954328

Last Updated: 2017-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

tDCS

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

Group Type: EXPERIMENTAL

tDCS

Intervention Type: 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.

Interventions

tDCS

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.

Intervention Type: DEVICE

Other Intervention Names

Transcranial Direct Current Stimulation

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

michal roll

Director of Research and Development

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nir Giladi, Prof.

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Locations

Hebrew Rehabilitation Center / Harvard Medical School

Roslindale, Massachusetts, United States

Site Status: RECRUITING

Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

United States; Israel

Central Contacts

Jeffrey M Hausdorff, PhD

Role: CONTACT

jhausdor@tlvmc.gov.il

972-3-6974958

Facility Contacts

Brad Manor, PhD

Role: primary

bradmanor@hsl.harvard.edu

617-632-8884

Lewis Lipsitz, MD

Role: backup

Jeffrey Hausdorff, PhD

Role: primary

jhausdor@tasmc.health.gov.il

Talia Herman, MScPT

Role: backup

talit@tasmc.health.gov.il

References

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.

Reference Type: RESULT

PMID: 24443958 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33526043 (View on PubMed)

Other Identifiers

TASMC-16-NG-0699-CTIL

Identifier Type: -

Identifier Source: org_study_id