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Brain Stimulation + Gait Training for Stroke Recovery
N/A
Recruiting
Led By Sangeetha Madhavan
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than 18 years
Walking speed lesser than 1.2 m/s
Must not have
Lesions involving the brainstem and cerebellum
Uncontrolled anti-spasticity medications during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to immediately after training and baseline to 3 months follow up
Summary
This trial is testing a brain stimulation protocol to improve walking outcomes in people with stroke. The goal is to understand the neural mechanisms associated with response to the intervention.
Who is the study for?
This trial is for adults who've had their first stroke more than 3 months ago, can walk at least 5 minutes with or without a walking aid but slower than 1.2 m/s, and have some movement in the affected leg. They shouldn't have severe muscle stiffness, major heart or lung diseases, certain mental impairments, skin conditions worsened by stimulation, metal head implants, pacemakers, recent concussions or be pregnant.
What is being tested?
The study tests if brain stimulation combined with ankle exercises and high-speed treadmill training improves walking after a stroke. It also looks into how the brain changes with this treatment. Participants will receive transcranial direct current stimulation (tDCS) alongside physical therapy interventions.
What are the potential side effects?
Possible side effects include mild discomfort or itching under the electrode during tDCS; fatigue from physical exercises; and risks associated with intense exercise like shortness of breath or increased heart rate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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I walk slower than 1.2 meters per second.
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I can move my ankle upwards at least 5 degrees.
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I have difficulty walking due to partial paralysis.
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My leg movement is moderately impaired.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to my brainstem or cerebellum.
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I am not taking any uncontrolled anti-spasticity medications.
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I frequently have headaches without a known cause.
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I have a history of seizures or epilepsy.
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I do not have any unhealed sores or ongoing infections.
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I experience increased sensitivity or pain from touch.
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I do not have uncontrolled heart, lung, or metabolic conditions.
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I am taking medication that could make me more prone to seizures.
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I have stiffness in my leg that limits its movement.
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I have a skin or scalp condition that might worsen with tDCS treatment.
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I have severe osteoporosis.
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I have skull abnormalities or fractures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to immediately after training and baseline to 3 months follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to immediately after training and baseline to 3 months follow up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Walking speed with 10 meter walk test
Secondary study objectives
Aerobic capacity
Ankle motor control
Ankle range of motion
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Priming+HIISTTExperimental Treatment3 Interventions
Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training
Group II: Sham+HIISTTPlacebo Group1 Intervention
Sham tDCS before high intensity interval speed based treadmill training
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,568,696 Total Patients Enrolled
20 Trials studying Stroke
2,325 Patients Enrolled for Stroke
University of Maryland, College ParkOTHER
158 Previous Clinical Trials
46,268 Total Patients Enrolled
6 Trials studying Stroke
564 Patients Enrolled for Stroke
Northwestern UniversityOTHER
1,649 Previous Clinical Trials
958,578 Total Patients Enrolled
34 Trials studying Stroke
25,331 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have very tight muscles in your ankles, which makes it hard to move them.My cancer has spread to my brainstem or cerebellum.I am not taking any uncontrolled anti-spasticity medications.You have a pacemaker implanted in your heart.I am older than 18 years.You have had skin rashes from touching certain substances in the past.You have difficulty understanding and following instructions or have trouble with memory and communication.I frequently have headaches without a known cause.You have low sensory function in your lower limbs according to a specific assessment scale.I have a history of seizures or epilepsy.You did not pass the exercise test.I had a stroke affecting one side of my brain over 3 months ago.I do not have any unhealed sores or ongoing infections.I experience increased sensitivity or pain from touch.I do not have uncontrolled heart, lung, or metabolic conditions.I am taking medication that could make me more prone to seizures.I walk slower than 1.2 meters per second.I can move my ankle upwards at least 5 degrees.You have metal implants in your head or face.You had a concussion in the past 6 months.I have stiffness in my leg that limits its movement.I have difficulty walking due to partial paralysis.I can walk for 5 minutes by myself, even with a cane or walker.I have a skin or scalp condition that might worsen with tDCS treatment.You have a strong reaction to things that touch your skin.I have severe osteoporosis.I have skull abnormalities or fractures.My leg movement is moderately impaired.
Research Study Groups:
This trial has the following groups:- Group 1: Priming+HIISTT
- Group 2: Sham+HIISTT
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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