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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03582904
Other study ID # 1240484
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 16, 2018
Est. completion date April 10, 2019

Study information

Verified date March 2020
Source University of Delaware
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 10, 2019
Est. primary completion date April 10, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms

  • no Condition Being Studied; tDCS Only in Healthy Subjects

Intervention

Procedure:
tDCS
real or sham tDCS delivered to primary motor cortex

Locations

Country Name City State
United States University of Delaware Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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