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New treatment option for Hereditary Spastic Paraplegia
Official title Neuromodulation to Enhance Motor Function in HSP
ClinicalTrials.gov ID: NCT07417943
What this study is testing
- What it's testing
- Hereditary spastic paraplegia (HSP) is a rare neurological condition that causes stiffness, weakness, and difficulty walking due to damage in the nerves that control movement. This study will test whether a noninvasive form of spinal cord stimulation, called transcutaneous spinal cord stimulation (tSCS), can improve walking and reduce muscle stiffness in adults with HSP.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinical diagnosis of hereditary spastic paraplegia (genetic confirmation if available).
- Stable medications for spasticity and other neurologic symptoms for =4 weeks prior to enrollment.
- Able to participate in study visits and assessments with or without assistive devices.
- If ambulatory: able to walk at least 10 meters with or without an assistive device.
- If wheelchair user: able to perform seated mobility tasks and transfers required for assessments.
You likely can't join if
- Implanted electronic devices (e.g., pacemaker, deep brain stimulator, intrathecal pumps).
- Severe cardiopulmonary disease that would make participation unsafe.
- Open skin lesions or severe dermatologic conditions at electrode sites.
- Pregnancy or plans to become pregnant during the intervention period.
- Diagnosed with Primary Lateral Sclerosis (PLS) or another neurological condition that affects walking, such as stroke, multiple sclerosis (MS), or a...
- Unable to participate in basic movement or mobility assessments, even with their usual mobility device (such as a wheelchair, walker, or cane)...
See the full eligibility criteria
- Clinical diagnosis of hereditary spastic paraplegia (genetic confirmation if available).
- Stable medications for spasticity and other neurologic symptoms for =4 weeks prior to enrollment.
- Able to participate in study visits and assessments with or without assistive devices.
- If ambulatory: able to walk at least 10 meters with or without an assistive device.
- If wheelchair user: able to perform seated mobility tasks and transfers required for assessments.
- Capacity to provide informed consent and follow study procedures, with an ability to communicate and understand instructions in English
- Implanted electronic devices (e.g., pacemaker, deep brain stimulator, intrathecal pumps).
- Severe cardiopulmonary disease that would make participation unsafe.
- Open skin lesions or severe dermatologic conditions at electrode sites.
- Pregnancy or plans to become pregnant during the intervention period.
- Diagnosed with Primary Lateral Sclerosis (PLS) or another neurological condition that affects walking, such as stroke, multiple sclerosis (MS), or a recent surgery on legs.
- Unable to participate in basic movement or mobility assessments, even with their usual mobility device (such as a wheelchair, walker, or cane). People who use wheelchairs or other mobility aids can participate if they...
- Cognitive or psychiatric conditions that make it difficult to give informed consent or follow study instructions.
- Diagnosed with Urinary Tract Infection (UTI), either acute or ongoing, before or at the time of study enrollment.
- Diagnosed with epilepsy.
- Participation in another treatment clinical trial that could affect mobility or spasticity during the study.
- A recent change (within the last 4 weeks) in medications or treatments that affect spasticity or movement (for example: baclofen, tizanidine, botulinum toxin injections).
- Expect to start or change treatments for spasticity or mobility during the study period.
- Any condition judged by the investigator to pose excess risk or confound outcomes.
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, 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.