The Short-term Effects of Noninvasive Electrical Brain Stimulation on Dual Tasking in Older Adults

NCT03191812 | Completed DMC

• 1 other identifier: 2016-26
• Study Type: interventional
• Target: 61
• Locations: 2 countries
• Sites: 2

Brief Summary

The tDCS \& Dual Tasking study will compare the effects of transcranial Direct Current Stimulation (tDCS) targeting three different cortical regions (as well as sham stimulation) on dual task standing and walking in older adults with and without a recent history of recurrent falls.

Conditions

Aging

Keywords

Falls; transcranial Direct Current Stimulation; Mobility; Dual Task

Outcome Measures

Primary Outcomes (2)

• Dual task cost to standing postural sway speed

  The dual task cost to standing postural sway speed will be calculated from trials of standing with and without simultaneous performance of a serial subtraction cognitive task. The dual task cost will be calculated as the percent change in sway speed from single- to dual-task conditions.

  This outcome will be assessed immediately before and after each 20-minute session of tDCS.

• Dual task cost to gait speed when walking

  The dual task cost to gait speed when walking will be calculated from trials of walking with and without simultaneous performance of a serial subtraction cognitive task. The dual task cost will be calculated as the percent change in gait speed from single- to dual-task conditions.

  This outcome will be assessed immediately before and after each 20-minute session of tDCS.

Secondary Outcomes (10)

• Dual task cost to postural sway area

  This outcome will be assessed immediately before and after each 20-minute session of tDCS.

• Dual task cost to gait variability when walking

  This outcome will be assessed immediately before and after each 20-minute session of tDCS.

• Single task postural sway speed

  This outcome will be assessed immediately before and after each 20-minute session of tDCS.

• Single task postural sway area

  This outcome will be assessed immediately before and after each 20-minute session of tDCS.

• Single task gait speed variability when walking

  This outcome will be assessed immediately before and after each 20-minute session of tDCS.

Study Arms (4)

Sham Stimulation

SHAM COMPARATOR

The Sham stimulation intervention will consist of one, twenty-minute session of transcranial direct current stimulation (tDCS) that does not target a cortical area but instead, provides just enough current to create tingling sensations across the scalp to mimic the feeling of receiving the real stimulation. The sham stimulation will use the same number and placement of electrodes as the real stimulation but with a much smaller total current intensity of 0.5 milliamps (mA).

Other: transcranial Direct Current Stimulation (tDCS)

M1 Stimulation

EXPERIMENTAL

The M1 stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the primary motor cortex at a total current intensity of 1.5 mA.

Other: transcranial Direct Current Stimulation (tDCS)

DLPFC Stimulation

EXPERIMENTAL

The DLPFC stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex at a total current intensity of 1.5 mA.

Other: transcranial Direct Current Stimulation (tDCS)

M1+DLPFC Stimulation

EXPERIMENTAL

The M1+DLPFC stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the primary motor cortex and the dorsolateral prefrontal cortex simultaneously at a total current intensity of 3.0 mA.

Other: transcranial Direct Current Stimulation (tDCS)

Interventions

transcranial Direct Current Stimulation (tDCS) OTHER

There will be three different tDCS targets as well as a sham stimulation condition. The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes.

DLPFC Stimulation; M1 Stimulation; M1+DLPFC Stimulation; Sham Stimulation

Eligibility Criteria

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

You may qualify if:

• "Faller" group
• Aged 65 years and older
• Able to read, write and communicate in English
• Self-report of 2 or more falls within the past 6 months
• "Non-Faller" Group
• Aged 65 years and older
• Able to read, write, and communicate in English
• Self-report of 1 or no (zero) falls within the past 6 months

You may not qualify if:

• Self-reported diagnosis of Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, history of stroke or other neurodegenerative disorder.
• Self-reported active cancer for which chemo-/radiation therapy is being received.
• Hospitalization within the past 3 months due to acute illness or as a result of a musculoskeletal injury significantly affecting gait and balance.
• Montreal Cognitive Assessment score \<18, or insufficient understanding of study procedures following review of the Informed Consent Form. Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
• Inability to stand or ambulate unassisted for at least 25 feet.
• Contraindications to tDCS, including a reported seizure within the past two years, use of neuro-active drugs, the risk of metal objects in the brain, skull, or head, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant), or the presence of any active dermatological condition, such as eczema, on the scalp (see appendix for standardized tDCS screening questionnaire).

Sponsors & Collaborators

• Hebrew SeniorLife: lead

Study Sites (2)

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131, United States

Location

Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

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

• Brad Manor

  Institute for Aging Research, Hebrew SeniorLife

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: May 26, 2017
• Primary Completion: November 26, 2019
• Study Completion: May 26, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (1)