NCT03582904

Brief Summary

The ability to change walking patterns is important for daily tasks such as stepping over an obstacle. This change of walking pattern can occur in a strategic manner, i.e., consciously making one step longer or shorter. Healthy individuals can learn a new walking pattern through perturbed visual feedback of their walking information (Kim et al., 2015; Kim et al., 2017). This type of learning is thought to largely involve explicit strategy. Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that can enhance learning of some motor tasks (Reis et al., 2009), and primarily has been studied in the upper extremity. In locomotor learning, prior recent work by the investigators has suggested that tDCS does not affect non-strategy based locomotor learning, and the investigators speculate that tDCS may benefit learning of strategic tasks instead. The purpose of this study is to determine if tDCS can enhance learning and retention of a new walking pattern in a strategy-based, visually guided locomotor task in healthy individuals. Two groups of young, healthy participants will be recruited to learn a new walking pattern through perturbed visual feedback, with retention of learning tested on the second day. One group will receive tDCS, which is expected to enhance learning. The other group will receive placebo stimulation and serve as a control. Results from this work will provide information on which type of motor learning is sensitive to enhancement with tDCS, and may help pave the path for utilizing tDCS for neurorehabilitation.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

July 16, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2019

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

9 months

First QC Date

June 14, 2018

Last Update Submit

March 30, 2020

Conditions

Keywords

motor learningtDCSlocomotion

Outcome Measures

Primary Outcomes (2)

  • Magnitude of Locomotor Learning

    Step length produced on the perturbed leg at the end of the learning period on study day 1 and subtracted from baseline (pre-learning period) step length

    study day 1

  • Magnitude of Locomotor Learning Retention

    Step length produced on the perturbed leg on study day 2, normalized to the Magnitude of Locomotor Learning achieved on study day 1

    study day 2

Study Arms (2)

Real tDCS

EXPERIMENTAL

Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered via saline-soaked sponge electrodes (anode, 8 cm\^2; cathode 38.4 cm\^2) at an intensity of 1.5 milliamperes over \< 30 minutes.

Procedure: tDCS

Control

SHAM COMPARATOR

Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered via saline-soaked sponge electrodes (anode, 8 cm\^2; cathode 38.4 cm\^2) at an intensity of 1.5 milliamperes over 2 minutes.

Procedure: tDCS

Interventions

tDCSPROCEDURE

real or sham tDCS delivered to primary motor cortex

ControlReal tDCS

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40 years
  • Medically stable and generally healthy
  • Able to walk on a treadmill without the use of handrails for 20 minutes at a speed of 1.0 m/s without rest
  • Resting heart rate ≤100 beats per minute
  • Resting blood pressure ≤140/90 mm Hg
  • Willing and able to attend all testing sessions

You may not qualify if:

  • Any chronic or recent medical conditions, including any musculoskeletal, cardiovascular, pulmonary, psychiatric or neurological diagnosis
  • Any impaired sensation or weakness in either lower extremity
  • History of serious traumatic head injury, defined as a loss of consciousness for more than 5 minutes and/or requiring medical treatment
  • Any history of acute or chronic problems with balance or more than 1 fall in the last 12 months
  • History of brain surgery
  • Taking 4 or more medications
  • Current or chronic pain located anywhere in the body
  • History of seizures
  • Currently pregnant (if a female of childbearing age)
  • Currently taking any medications that act on the central nervous system
  • Implanted pumps or stimulators above the shoulders
  • Metal aneurysm, other metal surgical clip placement, or any other metal in the head, face, or neck, except for dental fillings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Susanne M Morton, PhD, PT

    University of Delaware

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 14, 2018

First Posted

July 11, 2018

Study Start

July 16, 2018

Primary Completion

April 10, 2019

Study Completion

April 10, 2019

Last Updated

April 1, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations