Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal

May 8, 2026 updated by: Sangeetha Madhavan, University of Illinois at Chicago

Cortical Priming to Optimize Gait Rehabilitation: Renewal

Achieving functional ambulation post stroke continues to be a challenge for stroke survivors, clinicians, and researchers. In the effort to enhance outcomes of motor training, cortical priming using brain stimulation has emerged as a promising adjuvant to conventional rehabilitation. This project focuses on the development of a long term gait rehabilitation protocol using brain stimulation to improve walking outcomes in people with stroke. The project will also aim to understand the neural mechanisms that are associated with response to the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age greater than 18 years
  • First ever monohemispheric stroke > 3 months since onset
  • Residual hemiparetic gait deficits (e.g. abnormal gait pattern)
  • Able to walk for 5 minutes at self-paced speed. Handheld assistive device is acceptable.
  • Walking speed lesser than 1.2 m/s
  • Lower limb Fugl-Meyer Motor score between 15-30
  • At least 5 deg of ankle dorsiflexion necessary to perform the ankle-tracking task

Exclusion Criteria:

  • General exclusion criteria

    • Severe osteoporosis
    • Contracture-limiting range of motion of lower limb
    • Score of more than 2 on the Modified Ashworth Scale (indicating increased muscle tone through ankle range of motion)
    • Uncontrolled anti-spasticity medications during the study period
    • Score less than 6 on the Fugl-Meyer Sensory Assessment Scale for the Lower Limb
    • Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
    • Unhealed decubiti, persistent infection
    • Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE)<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the ankle-tracking task.
    • Lesions involving the brainstem and cerebellum
    • Failure to pass the graded exercise stress test

TMS exclusion criteria

  • Implanted cardiac pacemaker
  • Metal implants in the head or face
  • Unexplained, recurring headaches
  • History of seizures or epilepsy
  • Currently under medication that could increase motor excitability and lower seizure threshold
  • Skull abnormalities or fractures
  • Concussion within the last 6 months
  • Currently pregnant

tDCS exclusion criteria

  • Skin hypersensitivity
  • History of contact dermatitits
  • History of allodynia and/or hyperalgesia
  • Any other skin or scalp condition that could be aggravated by tDCS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Priming+HIISTT
Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training
Other: Transcranial direct current stimulation (tDCS)
1 mA tDCS
Other: Ankle motor training
Visuomotor target tracking task
Behavioral: High intensity interval speed based treadmill training (HIISTT)
Each treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.
Sham Comparator: Sham+HIISTT
Sham tDCS before high intensity interval speed based treadmill training
Behavioral: High intensity interval speed based treadmill training (HIISTT)
Each treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Walking speed with 10 meter walk test
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up
Self-selected and fastest gait speed will be measured as the average of 3 trials of the 10-m walk test (10MWT).
Change from baseline to immediately after training and baseline to 3 months follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Walking spatiotemporal characteristics with GAITRite walkway
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up
Spatiotemporal parameters of walking will be assessed using a 7m long pressure sensitive mat (GAITRite walkway).
Change from baseline to immediately after training and baseline to 3 months follow up
Motor impairment with Fugl Meyer Lower Extremity Scale
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up
Lower extremity impairment will be measured using the Fugl Meyer Lower Extremity Scale (FMLE), a series of tests of movement, reflex activity, coordination/speed, sensation, and range of motion. The maximum score is 34 and a high score indicates less impairment
Change from baseline to immediately after training and baseline to 3 months follow up
Walking endurance with 6-minute walk test
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up
Walking endurance will be measured using the 6-Minute Walk test. Participants will walk as far as possible within 6 minutes.
Change from baseline to immediately after training and baseline to 3 months follow up
Ankle range of motion
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up
Ankle range of motion will be measured using a wireless electrogoniometer affixed to the ankle.
Change from baseline to immediately after training and baseline to 3 months follow up
Ankle motor control
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up
The participant will track a computer-generated sinusoidal target with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device. Accuracy of tracking the target with ankle motion will be calculated.
Change from baseline to immediately after training and baseline to 3 months follow up
Balance with mini Balance Evaluations Systems Test (miniBESTest)
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up.
Balance will be tested with the Mini-BESTest, involving 14 different tasks to challenge balance.
Change from baseline to immediately after training and baseline to 3 months follow up.
Aerobic capacity
Time Frame: Change from baseline to immediately after training.
Cardiopulmonary exercise tests will be performed on a motorized treadmill following an individualized protocol using standard procedures. Measures relating to peak oxygen consumption (VO2 max) will be calculated.
Change from baseline to immediately after training.
Quality of Life with EuroQol-5D (EQ-5D)
Time Frame: Change from baseline to immediately after training.
Quality of life will be measured with the EuroQol-5D (EQ-5D), a questionnaire with questions designed to assess aspects of quality of life.
Change from baseline to immediately after training.
Disability with Modified Rankin Scale
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up.
Global disability will be measured with the modified Rankin Scale, a simple 0-6 rating scale.
Change from baseline to immediately after training and baseline to 3 months follow up.
Community ambulation with wearable sensors
Time Frame: Change from baseline to immediately after training.
Daily ambulation will be assessed using an accelerometer.
Change from baseline to immediately after training.
Serum brain derived neurotrophic growth factor (BDNF)
Time Frame: Change from baseline to immediately after training.
5 ml of blood will be collected from a vein in the participants' arms
Change from baseline to immediately after training.
Corticomotor excitability using transcranial magnetic stimulation
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up.
Corticomotor excitability of the paretic and non-paretic lower limb muscles such as the tibialis anterior and soleus muscle representations will be measured with single pulse transcranial magnetic stimulation (TMS).
Change from baseline to immediately after training and baseline to 3 months follow up.
Cognitive function using Mini Mental Screening Examination
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up.
30-point questionnaire used to capture orientation, attention, memory and language.
Change from baseline to immediately after training and baseline to 3 months follow up.
Depression using Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up.
The 9-point questionnaire is used to measure degree of depression.
Change from baseline to immediately after training and baseline to 3 months follow up.
Modified Ashworth Scale
Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up.
The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion,
Change from baseline to immediately after training and baseline to 3 months follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Northwestern University
University of Maryland, College Park

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sangeetha Madhavan, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-0502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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