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Found 14 Actively Recruiting clinical trials

S

Actively Recruiting

Healthy Volunteer

Spinal cord injury SCI occurs when trauma or other factors damage the spinal cord, disrupting communication between the body and brain. This can lead to changes in body awareness called disembodiment, where sensations feel different or limbs seem out of place. The study aims to explore how SCI affects embodiment, its impact on daily life, and the related brain activity using functional magnetic resonance imaging fMRI. Both individuals with SCI and healthy participants will take part in this research. Participants will be divided into groups some with SCI will undergo a detailed behavioral assessment of embodiment and sensory-motor symptoms, while others will also have brain activity measured through fMRI during a task involving a modified rubber hand illusion. Healthy controls will perform similar behavioral assessments, with some also undergoing fMRI. The fMRI task includes watching virtual legs being touched while their own legs are stroked to assess the feeling of embodiment. Each participant will attend one examination lasting about 2 to 2.5 hours, including approximately 55 minutes inside the MRI scanner. Researchers will evaluate responses to questionnaires measuring body feelings, pain, emotions, cognition, and daily functioning. Brain activity and embodiment strength will also be assessed. The study will monitor various physical, psychological, and quality of life aspects to understand how SCI changes body awareness.

Age: 18Years - 65YearsAll Genders
1 location
S

Actively Recruiting

Researchers are evaluating ARC-IM Therapy, which uses epidural electrical stimulation, to support and promote the recovery of walking and other ambulatory functions in people with subacute and chronic spinal cord injuries. The study includes adults aged 18 to 65 who have sustained a traumatic spinal cord injury either less than 6 weeks ago subacute or more than 1 year ago chronic. The goal is to assess the safety and preliminary effectiveness of this device in improving mobility. All participants will receive the ARC-IM Therapy, which delivers electrical impulses to the lower spinal cord region to aid walking. The study groups are divided by injury timing one group with injuries less than 6 weeks old and another with injuries more than 1 year old. This device treatment will be monitored continuously throughout the study. Participants will undergo assessments including neurological classification, walking tests 10-Meter Walk Test, 6-Minute Walk Test, Timed Up and Go, walking indexes, gait analysis, goal attainment, and balance scales at baseline and multiple intervals up to 42 weeks after surgery. Safety is closely monitored throughout the study, focusing on any serious or related adverse events from implantation until study end, which can last up to 6 years. Participants must attend all scheduled visits and comply with the study requirements.

Age: 18Years - 65YearsAll GendersPhase Not Applicable
2 locations
E

Actively Recruiting

Researchers are studying voltage gated sodium channel NaV1.7 related pain in people with neuropathic pain and chronic postoperative pain. The goal is to better understand how these channels affect pain responses, especially in unmyelinated skin nerve fibers. This research focuses on characterizing pain in these conditions and how it relates to NaV1.7 channel activity. The study uses slow, sinus-like electrical skin stimulation to activate certain nerve fibers that may cause pain at low intensities in affected patients. Pain in chronic postoperative scars will also be examined using laser-evoked potentials LEP and a range of quantitative sensory tests QST. Participants complete pain-related questionnaires to provide additional information about their pain experiences. Participants will undergo various assessments including pain intensity measurements during electrical stimulation, baseline sensory thresholds for heat, cold, and mechanical stimuli, and nerve response evaluations. Psychological aspects such as anxiety and depression are also measured. This observational study monitors changes over time without administering treatments. The total study period and participant involvement details are based on scheduled assessments and sensory testing.

Age: 18Years - 65YearsAll Genders
1 location
S

Actively Recruiting

Researchers are investigating the use of a powered exoskeleton combined with functional electrical stimulation FES for people with chronic spinal cord injury SCI. This trial compares the combined therapy to exoskeleton therapy alone to assess improvements in walking and other health functions. The study addresses the potential benefits of merging over-ground robotic therapy with FES, which individually have shown positive effects on muscle strength, endurance, and mobility after SCI. Participants will be randomly assigned to one of two groups one will train with the EksoNR powered exoskeleton combined with gait-synchronized FES using the FES RehaMove2 device, and the other will train with the EksoNR exoskeleton alone. Training lasts 8 weeks, with three sessions per week, each session involving 30 minutes of active training. The trial evaluates how combining these therapies affects functional outcomes and secondary health parameters compared to exoskeleton therapy without FES. During the study, participants walking speed, gait function, endurance, balance, muscle strength, and quality of life will be assessed before training, immediately after the 8-week training, and again three months later. Researchers will also monitor training duration, intensity, volume, and cardio-respiratory function throughout the program. The main outcome measured is the change in preferred walking speed shortly after training, with additional measures collected over time to evaluate lasting effects.

Age: 18Years +All GendersPhase Not Applicable
1 location
S

Actively Recruiting

Researchers are evaluating two different types of functional electrical stimulation FES leg exercises for patients with spinal cord injury SCI. The study aims to compare FES-induced leg aerobic fitness and leg strength in adults aged 18 to 75 years who have motor complete SCI between spinal levels C7 and T10. Patients who are sub-acute, meaning more than 6 weeks post-trauma, will be included in this randomized trial. Participants will be assigned to one of two exercise groups a high-intensity interval training group HI-SHORT or a low-moderate continuous training group LO-LONG. Both groups will exercise using the Hasomed RehaStim ergometer three to four times weekly over 6 to 8 weeks, completing 24 therapy sessions. The HI-SHORT group will perform 10 intervals of 2 minutes each at high intensity with 1 to 2 minutes of rest between intervals, while the LO-LONG group will perform continuous leg exercise lasting 20 or more minutes at lower intensity. Exercise intensity is adjusted by the electrical stimulation current, ranging from about 90-150 milliamperes depending on the group and patient. Throughout the study, primary outcomes like aerobic fitness and secondary outcomes such as muscle oxygenation measured by near-infrared spectroscopy and leg strength will be assessed before training and after completing the 6 to 8 weeks of exercise. Participants must be able to perform FES muscle contractions and follow verbal instructions. Safety and progress will be monitored during the sessions, and the overall study participation spans the 6 to 8 week intervention period.

Age: 18Years - 75YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the safety, tolerability, and pharmacokinetics of NG004, a human monoclonal antibody administered intrathecally, in patients with acute incomplete cervical spinal cord injury SCI. This first-in-human, multicenter, open-label trial aims to determine the maximum tolerated dose of NG004 through multiple ascending doses. The study focuses on individuals with acute cervical SCI classified as ASIA impairment scale C-D, within 4 to 28 days after injury. Participants will receive repeated intrathecal injections of NG004 across four different dose regimens. The trial does not include a placebo group and involves sequential dosing to assess safety and drug behavior in the body. Treatment monitoring will continue up to 6 months after the last injection to measure drug levels and half-life. Throughout the study, participants will be closely observed for adverse events, serious adverse events, and reactions related to NG004 starting from treatment initiation up to 6 months. Blood samples will be taken at specific times after injections to analyze drug concentration and how long it stays in the bloodstream. The trial will include patients aged 18 to 70 years who are hemodynamically stable and do not require full mechanical ventilation. The total study duration for each participant extends through the treatment and follow-up periods.

Age: 18Years - 70YearsAll GendersPhase 1
6 locations
S

Actively Recruiting

Researchers are studying the outcomes after removing the tracheal cannula decannulation in adult patients hospitalized at the Swiss Paraplegic Centre Nottwil SPC. This observational study evaluates the rate of physical complications, such as those requiring treatment, intubation, recannulation, or leading to death, over three months following decannulation. The study also explores patients perspectives and clinical protocols related to decannulation. This study does not involve any experimental treatments but closely monitors patients who have undergone decannulation during their hospital stay at SPC. The research team collects information at multiple time points 4 days, 1 month, and 3 months after the tracheal cannula is removed. The study aims to describe short- and long-term complications, assess factors that predict these complications, and evaluate the clinical decannulation process. Participants will be followed over a three-month period with assessments that include questionnaires about their experiences and clinical evaluations of any physical complications. Data collection also includes measuring rates of reintubation, recannulation, and death. The study uses standardized questionnaires and clinical data to understand outcomes and patient perspectives, helping to improve knowledge about decannulation management in this patient group.

Age: 18Years +All Genders
1 location
C

Actively Recruiting

This research aims to compare the effects of robot-assisted therapy using the ArmeoSpring device with conventional occupational therapy on upper limb function in individuals with cervical spinal cord injury cSCI. It focuses on determining which therapy better improves arm and hand function during the intermediate phase of injury, between 2 weeks and 6 months post-injury. The study is designed as a cross-over trial where participants receive both therapies in random order to assess their effectiveness. Participants undergo two consecutive 6-week therapy periods. One period involves unilateral robot-assisted therapy using the ArmeoSpring, an arm orthosis providing adjustable antigravity support with a spring system, delivered 3 times per week for 30 minutes each session. The other period involves unilateral conventional occupational therapy consisting of strengthening, grasping, fine motor, and activity-based tasks with the same frequency and duration. The order of therapies is randomly assigned, with assessments conducted before, between, and after the therapy periods. Throughout the study, participants complete baseline, intermediate, post, and follow-up assessments measuring grasp performance, upper limb function quality, independence in daily activities, motor scores, hand strength, arm control, therapy intensity, and motivation. The follow-up assessment occurs if the post-assessment was done before 150 days post-injury. This allows researchers to monitor changes over time and compare the impact of each therapy on upper limb recovery and daily functioning.

Age: 18Years +All GendersPhase Not Applicable
1 location
P

Actively Recruiting

Researchers are evaluating the safety and feasibility of two versions of the TWIICE Rise, a robotic exoskeleton designed to help patients with spinal cord injury walk. The study includes two phases the first with TWIICE Rise 0.0 involving 5 patients over 6 clinic sessions, and the second with TWIICE Rise 1.0 involving 10 patients over 10 sessions in various settings including clinic, home, and community. This approach allows assessment of device improvements and real-world use for people with spinal cord injuries. Participants in phase 1 complete a training program with TWIICE Rise 0.0 twice a week for 6 weeks, totaling 6 sessions in a clinical setting. Phase 2 participants train with the updated TWIICE Rise 1.0 two to three times a week for up to 10 weeks, totaling 10 sessions that start in a rehabilitation center to learn walking skills, then continue at home and in the community once sufficient skills are achieved. The exoskeleton supports walking under supervision of trained coaches. During the study, various safety and feasibility measures are closely monitored, including adverse device effects, heart rate, blood pressure, pain, fatigue, skin condition, number of steps, walking speed, and walking surface. Mobility skills and performance on walking tests are assessed throughout, with data collected over the full training period. The study helps determine if the exoskeleton can safely and effectively assist walking for patients with spinal cord injuries over a 10-week intervention.

Age: 18Years - 70YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are investigating how home-based shoulder strength training affects shoulder health in people who use manual wheelchairs due to recent spinal cord injuries in the thoracic or lumbar spine. The study aims to find out if starting the training 3 months versus 12 months after discharge from primary rehabilitation makes a difference. This research focuses on preventing shoulder pain and improving shoulder function to support long-term health and independence. Participants will follow a personalized home-based strength training program consisting of six exercises performed twice a week for 12 weeks. The training starts either 3 months or 12 months after discharge from rehabilitation, with participants randomly assigned to one of these two groups. This setup allows comparison of early versus late intervention effects on shoulder health. Throughout the 15-month study, participants undergo six evaluations every three months, including questionnaires on independence, participation, quality of life, and physical activity. Assessments also measure shoulder strength, range of motion, and function. Wheelchair use is tracked for one week at each timepoint using sensors on the wheelchair and wrist, followed by a questionnaire about shoulder pain. Additionally, four MRI scans of the shoulder are performed to evaluate shoulder condition, muscle volume, and quality. These measures help researchers understand the relationship between daily shoulder load and rehabilitation preparation.

Age: 18Years - 70YearsAll GendersPhase Not Applicable
1 location

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