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New treatment option for Spinal Cord Injury
Official title Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait
ClinicalTrials.gov ID: NCT03053791
What this study is testing
- What it's testing
- Spinal cord injuries are anatomically mostly incomplete, showing tissue bridges of the spinal cord at the injury site. Of the 60% functionally incomplete patients, about half face a life in the wheelchair.
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 75
You may be able to join if
- Informed Consent
- Participation in two assessment sessions before enrollment (Screening and baseline)
- Willingness and ability to comply with the protocol and to attend required study training and visits
- Male or female people
- Age 18-75
You likely can't join if
- Enrollment of the investigator, his/her family members, employees and other dependent persons
- Limitation of standing and walking function based on accompanying (CNS) disorders
- Cardiovascular disorders restricting physical training or peripheral nerve disorders
- Implanted technical devices (pacemaker, defibrillator)
- History of significant autonomic dysreflexia
- Cognitive disorders/brain damage
See the full eligibility criteria
- Informed Consent
- Participation in two assessment sessions before enrollment (Screening and baseline)
- Willingness and ability to comply with the protocol and to attend required study training and visits
- Male or female people
- Age 18-75
- Motor incomplete SCI
- Level of lesion: T10 and above, based on AIS level, preservation of sacral function
- Focal spinal cord disorder caused by either trauma or non-traumatic and non-progressive condition (like hemorrhage, benign tumor)
- Minimum 3 months of recovery after SCI
- Completed in-patient rehabilitation program
- WISCI II, level \>2 (0-20 items): assistance of one or more persons. Ability to walk at least 10 meters
- Stable medical and physical condition.
- Adequate care-giver support and access to appropriate medical care in patient's home community
- Enrollment of the investigator, his/her family members, employees and other dependent persons
- Limitation of standing and walking function based on accompanying (CNS) disorders
- Cardiovascular disorders restricting physical training or peripheral nerve disorders
- Implanted technical devices (pacemaker, defibrillator)
- History of significant autonomic dysreflexia
- Cognitive disorders/brain damage
- Drug refractory epilepsy
- Severe joint contractures disabling or restricting lower limb movements
- Haematological disorders with increased risk of bleeding during surgical interventions
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Congenital or acquired lower limb abnormalities (affection of joints and bone)
- Women who are pregnant or breast feeding or planning a pregnancy during the course of the study
- Lack of safe contraception
- Inability of the participant to follow the procedures of the study, e.g. due to language problems, psychological problems, dementia etc.
- Known or suspected non-compliance, drug or alcohol abuse
- Current or prior malignancy
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Switzerland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Switzerland. 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.