Recruiting

Cortical Priming

Sponsor:

University of Illinois at Chicago

Code:

NCT04477330

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcranial direct current stimulation (tDCS)

Ankle motor training

High intensity interval speed based treadmill training (HIISTT)

Study Details

Brief summary:

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.

Conditions

Stroke

Study ID

NCT04477330

Start date

Sep 1, 2020

Status verified date

Aug, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Priming+HIISTT

Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training

sham comparator: Sham+HIISTT

Sham tDCS before high intensity interval speed based treadmill training

Interventions

Transcranial direct current stimulation (tDCS)

1 mA tDCS

Ankle motor training

Visuomotor target tracking task

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.

Primary outcome measure

  • Walking speed with 10 meter walk test [ Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up ]

Central Contacts and Locations

Central contacts

Sangeetha Madhavan

3123552517smadhava@uic.edu

Locations

Physical Therapy

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Sangeetha Madhavan

brainlab@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

May 11, 2026

Last verified

Aug, 2025

Keywords

  • tDCS
  • Walking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-05-11.