no Condition Being Studied; tDCS Only in Healthy SubjectsNCT03582904
Using tDCS to Enhance Learning of a New Walking Pattern
A study testing tDCS in people with no Condition Being Studied; tDCS Only in Healthy Subjects, run by University of Delaware at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- no Condition Being Studied; tDCS Only in Healthy Subjects
- What is being tested?
- tDCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2018to 10 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- tDCS
- Keywords
- motor learning, tDCS, locomotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSProcedure or surgery
real or sham tDCS delivered to primary motor cortex
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: study day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start16 Jul 2018
- Primary completion10 Apr 2019
- Study completion10 Apr 2019
Why it stopped: Pilot data suggested the paradigm would need significant revision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for no Condition Being Studied; tDCS Only in Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne M Morton, University of Delaware
- Investigators
- Susanne M Morton, PhD, PT, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582904
- Sponsor's protocol ID
- 1240484
- Status last verified
- Mar 2020
- First submitted
- 14 Jun 2018
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using tDCS to Enhance Learning of a New Walking Pattern
- ClinicalTrials.gov ID
- NCT03582904
- Acronym / sponsor ID
- 1240484
- Keywords
- motor learning, tDCS, locomotion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Pilot data suggested the paradigm would need significant revision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real tDCS | Experimental | Procedure: tDCSAnodal 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. |
| Control | Sham comparator | Procedure: tDCSAnodal 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSreal or sham tDCS delivered to primary motor cortex | Procedure or surgery | Control, Real tDCS |
Primary outcome
Magnitude of Locomotor Learning
Time frame: study day 1
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
Magnitude of Locomotor Learning Retention
Time frame: study day 2
Step length produced on the perturbed leg on study day 2, normalized to the Magnitude of Locomotor Learning achieved on study day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne M Morton, PhD, PT principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with no Condition Being Studied; tDCS Only in Healthy Subjects, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of Locomotor Learning (time frame: study day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.