Clinical Research Directory

UTSW NORC Pilot Spinal Cord Injury Dietary Program

The goal of this observational study is to learn about the effects of a 9-week dietician-guided program modified from the National Diabetic Prevention Program (modified DPP-diet) in people with spinal cord injury on body composition and insulin sensitivity. The main question it aims to answer is: Does 9 week modified DPP-diet reduce body fat percentage and insulin resistance? Participants will: Have 9 weeks of Telehealth visit with dietician certified in providing DPP. Visit the laboratory before, immediately and 9 weeks after completion of the modified DPP-diet. Share with the researcher on the perceived benefit and obstacles in implementing the modified DPP-diet as part of their daily activities.

A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord Injury

The DOSED clinical study evaluates the safety and utility of a novel delivery device to deliver LCTOPC1, a cell therapy, to the spinal cord of patients with a spinal cord injury (SCI). LCTOPC1 is designed to replace or support cells that are absent or dysfunctional due to traumatic injury, with a goal to help improve the quality of life and restore or augment functional activity in persons suffering from a traumatic cervical or thoracic injuries.

Non-Invasive Interventions for Respiratory Recovery in Chronic Spinal Cord Injury

Spinal cord injuries (SCI) can seriously affect a person's ability to breathe. This happens because the injury can damage the nerves that control the muscles used for breathing. As a result, people with SCI often face breathing problems, a higher risk of lung infections, and even early death. While breathing exercises can help strengthen these muscles, they often aren't intense enough to make a big difference, especially in people with long-term injuries. This research project is exploring a new way to improve breathing in people with chronic SCI. The goal is to "wake up" the remaining nerve pathways that still connect the brain and spinal cord to the breathing muscles. By doing this, the investigators hope to make breathing exercises more effective and improve overall respiratory health. The investigators are testing a combination of two non-invasive (non-surgical) techniques: Transcutaneous Spinal Cord Stimulation (tSCS): This uses small electrical pulses delivered through the skin to stimulate the spinal cord and help activate the muscles used for breathing. Hypercapnic-Hypoxia Protocol (HiCO₂-AIH): This involves breathing air with lower oxygen and higher carbon dioxide for short periods. This naturally increases the brain's drive to breathe and may help strengthen the breathing muscles. The investigators believe that using these two techniques together will "prime" the nervous system, making it more responsive to breathing exercises. This could lead to better outcomes for people with SCI. In addition to testing this treatment, the investigators are also collecting saliva and blood samples to look for biomarkers-biological clues that might help predict who will benefit most from this therapy. These include genetic markers and signs of nerve damage in the blood. Who Can Participate The investigators are looking for adults aged 18 to 70 who: Have had a spinal cord injury for at least one year. Have an injury between the neck and upper back (from C3 to T8). Have an incomplete injury (some nerve function remains). Are medically stable and cleared by a doctor. Have at least a 20% reduction in breathing strength. What Participants Will Do Each participant will complete four rounds of treatment. Each round includes four days in a row of therapy, followed by a three-week break before the next round. Each daily session lasts about two hours and includes: Breathing special air mixtures (low oxygen and high carbon dioxide) for short periods, followed by normal air. A short break. Then, spinal cord stimulation combined with breathing exercises that use resistance (like breathing through a straw). What the Investigators Will Measure The investigators will track: Breathing ability using lung function tests and pressure measurements. Nerve activity using brain and spinal cord stimulation to see how well the diaphragm (the main breathing muscle) responds. Safety by monitoring oxygen levels, heart rate, blood pressure, and breathing responses during each session. Biological Samples Participants will provide: A one-time saliva sample for genetic testing. A one-time blood sample to look for markers of nerve injury. Why This Matters This study could lead to new, non-invasive treatments that improve breathing and quality of life for people living with spinal cord injuries. By identifying who is most likely to benefit from this therapy, the investigators can also move toward more personalized and effective care in the future.

BCI-Assisted SCS-EXS for Gait Optimization

The goal of this clinical trial is to evaluate the safety and technical feasibility of a novel brain-machine interface (BCI)-assisted spinal cord stimulation (SCS) and exoskeleton (EXS) system in patients with spinal cord injury (SCI). The primary aim is to determine whether the BCI-SCS-EXS system can safely and effectively improve lower limb motor function and quality of life in individuals with chronic SCI. Participant Population: Adults aged 14-65 years (sex/gender not limited). Patients with chronic SCI (≥6 months post-injury) classified as ASIA A, B, or C. Individuals with stable health status, MMSE ≥22, and secondary education or above. Primary Questions: 1. Is the BCI-SCS-EXS system safe and technically feasible for SCI rehabilitation? 2. Does the system improve lower limb motor function and quality of life in SCI patients? Interventions: Participants will undergo the following procedures: Phase I (Implantation): BCI implantation: ECoG electrodes placed over the motor cortex to decode lower limb movement intent. SCS electrode implantation: 5-6-5 paddle electrodes at T11-L2 for targeted spinal cord stimulation. Phase II (System Calibration): BCI-SCS synchronization: Calibration of decoded motor intent to trigger SCS parameters. SCS-EXO synchronization: Integration of SCS pulses with exoskeleton-assisted gait training. Phase III (Rehabilitation): Daily BCI-SCS-EXS training sessions (60 minutes, 5 times/week for 1 year). Adaptive adjustments to stimulation parameters and exoskeleton support based on performance. Remote monitoring of device performance and emergency intervention for technical issues. Outcome Measures: Primary: Safety (adverse events, device performance, synchronization metrics). Secondary: Efficacy (motor function, neurophysiological function, quality of life). Ethics and Safety: Informed consent will be obtained from all participants. Adverse events will be monitored and reported according to CTCAE 5.0 guidelines. Participant confidentiality will be strictly maintained. This study will provide foundational evidence for the safety and feasibility of the BCI-SCS-EXO system, paving the way for future randomized controlled trials in SCI rehabilitation.