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New treatment option for Hemiplegia and/or Hemiparesis Following Stroke
Official title Effect of Transcutaneous Electrical Nerve Stimulation on Post-stroke Patients
ClinicalTrials.gov ID: NCT06541015
What this study is testing
- What it's testing
- The subjects will be asked to attend minimum 15 separate sessions, 6 for testing changes in reflex behaviors, 3 for testing changes in the influence of descending motor tracts on spinal motor neurons, 3 for each testing functional movement in response to a trip event and cross-tilt walking adaptation pattern, as part of their participation in the research study. The estimated amount of time to enroll and collect the data for each of the subjects is four months' time.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Post Stroke Cohort:
- History of single unilateral stroke with subsequent lower limb hemiparesis on either side (\> 6 months since onset)
- Ability to walk as part of activities of daily living
- Age between 18 and 80
You likely can't join if
- Presence of concurrent severe medical illness including unhealed pressure sore, active or untreated infection, thromboembolic disease, severe...
- History of any neurological injury other than a single stroke
- Has received a Botox injection in the lower extremity within the last 4 months
- Any cognitive deficit that would prevent informed consent or ability to perform the experiment
- History of prior injury or surgery to the hip or knee
- Presence of significant lower extremity edema - Presence of cardiac pacemaker or any other electrically implanted device - Use of braces limiting...
See the full eligibility criteria
- Post Stroke Cohort:
- History of single unilateral stroke with subsequent lower limb hemiparesis on either side (\> 6 months since onset)
- Ability to walk as part of activities of daily living
- Age between 18 and 80
- Presence of concurrent severe medical illness including unhealed pressure sore, active or untreated infection, thromboembolic disease, severe contracture, osteoporosis, heterotropic classification, lower limb fracture...
- History of any neurological injury other than a single stroke
- Has received a Botox injection in the lower extremity within the last 4 months
- Any cognitive deficit that would prevent informed consent or ability to perform the experiment
- History of prior injury or surgery to the hip or knee
- Presence of significant lower extremity edema - Presence of cardiac pacemaker or any other electrically implanted device - Use of braces limiting harness/Lokomat fit (Any spinal orthoses such as TLSO, HALO)
- Weight greater than 300 pounds
- Adults unable to consent, infants, children, teenagers, pregnant women and prisoners will not be included in the study
- Clinically significant depression, psychiatric disorders, or ongoing drug abuse
- Actively taking medications with agents known to increase (e.g. amphetamines) or decrease motor system excitability
- Suffered a concussion in the last 6 months.
- Unexplained headaches Healthy Cohort: Inclusion Criteria:
- No history of stroke, cerebral palsy, injury or surgery to the lower limb.
- Currently not taking any central nervous system (CNS) affecting medication.
- Ability to walk as part of activities of daily living
- Age between 18 and 80 Exclusion Criteria:
- Presence of concurrent severe medical illness including unhealed pressure sore, active or untreated infection, thromboembolic disease, severe contracture, osteoporosis, heterotropic classification, lower limb fracture...
- History of any neurological injury
- Taking any medication affecting change in CNS
- Any cognitive deficit that would prevent informed consent or ability to perform the experiment
- History of prior injury or surgery to the hip or knee
- Presence of significant lower extremity edema - Presence of cardiac pacemaker or any other electrically implanted device - Use of braces limiting harness/Lokomat fit (Any spinal orthoses such as TLSO, HALO)
- Weight greater than 300 pounds
- Adults unable to consent, infants, children, teenagers, pregnant women and prisoners will not be included in the study
- Clinically significant depression, psychiatric disorders, or ongoing drug abuse
- Actively taking medications with agents known to increase (e.g. amphetamines) or decrease motor system excitability
- Suffered a concussion in the last 6 months.
- Unexplained headaches
- Has received a Botox injection in the lower extremity within the last 4 months
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.