Transformation of Paralysis to Stepping

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main goal of the project is to develop multiple noninvasive neuromodulatory strategies to facilitate full weight bearing stepping overground in people with paralysis. We will determine the effectiveness of combining noninvasive spinal cord stimulation and the administration of buspirone (a monoaminergic agonist) in facilitating locomotor activity in a gravity-neutral apparatus, during body weight supported stepping on a treadmill, when stepping overground in an assistive robotic exoskeleton, or during full weight bearing stepping overground in a rolling walker. Our objective is to identify the experimental variables that define the efficacy of these novel neuromodulatory techniques over a 5 year period in 15 participants with severe spinal cord injury who are at least one year post-injury.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Spinal Cord Neuromodulation for Spinal Cord Injury

NCT02313194

Cervical Spinal Cord Injury Tetraparesis Tetraplegia

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Neuromodulation of Spinal Locomotor Circuitry to Elicit Stepping After Pediatric Spinal Cord Injury

NCT04077346

Spinal Cord Injuries

ENROLLING_BY_INVITATION NA

SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

NCT05041114

Neurologic Disorder Paralysis Paralysis; Stroke +7 more

WITHDRAWN NA

Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury

NCT04458324

Spinal Cord Injuries

RECRUITING PHASE2

Epi Stim to Facilitate Standing and Stepping

NCT02339233

Spinal Cord Injury

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Aim 1: Define the relative effectiveness of transcutaneous electrical stimulation at multiple stimulation spinal sites and oral Buspirone in facilitating nonweight-bearing (gravity neutral device, GND) and weight-bearing (treadmill) stepping in individuals with chronic motor complete paralysis.

Aim 1.1: Define the relative effectiveness of transcutaneous electrical stimulation at multiple spinal sites to facilitate non-weight-bearing (GND) and weight-bearing (treadmill) stepping in spinal cord injury subjects.

Aim 1.2: Define the relative effectiveness of transcutaneous electrical stimulation at multiple spinal sites plus oral Buspirone to facilitate nonweight-bearing (gravity neutral device, GND) and weight-bearing (treadmill) stepping in spinal cord injury subjects.

Aim 2: Determine the relative effectiveness of Ekso-technology combined with transcutaneous electrical stimulation and/or oral Buspirone in lowering the robotic assistance and enhancing the ability to step self-assisted in a rolling walker during over-ground stepping in individuals with a chronic, severe (AIS A/B) spinal injury.

Aim 3: Determine the relative effectiveness of Ekso-technology combined with transcutaneous electrical stimulation and/or oral Buspirone in lowering the robotic assistance and enhancing the ability to step self-assisted in a rolling walker during over-ground stepping in individuals with motor incomplete (AIS C) paralysis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

This is a double blinded crossover study with three experimental groups. Each group will receive a combination of activity based neuromodulation interventions while receiving oral Buspirone or placebo. The crossover between drug or placebo administration will occur at the study phase midpoint.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Due to the objectives of the study, the identity of test and control treatments will not be known to investigators, research staff, or participants during the Treatment Phase. The following study procedures will be in place to ensure double-blind administration of study treatments. Access to the randomization code will be strictly controlled.

* Packaging and labeling of test and control treatments will be identical to maintain the blind.
* The study blind will be broken on completion of the clinical study and after the study database has been locked.

BuSpar (buspirone) and matching placebo tablets (2x/day) will be obtained and dispensed by the investigational pharmacy.

Study drug and placebo will be labeled with the required FDA warning statement, the protocol number, a treatment number, the name of the sponsors, and directions for patient use and storage.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Complete Spinal Cord Injury - Gravity Neutral Stepping

Group 1 will begin with a 3-4-month preparation phase and up to 12 sessions in the gravity neutral device (GND) will occur. The training sessions in the GND will be used to obtain the optimal stimulation parameters. Next, participants will enter Intervention Phase 1 where they will receive training sessions 3 days/week for approximately 2 hours. This will be done in the GND in the presence of stimulation. Afterwards, Intervention 2 will include the same training procedures with the addition of Buspirone or Placebo in a cross-over fashion halfway through this phase.

Group Type EXPERIMENTAL

Buspirone

Intervention Type DRUG

Oral Buspirone 7.5mg - 10mg daily during the treatment phase.

Non-invasive Spinal Cord Stimulation

Intervention Type DEVICE

A non-invasive transcutaneous electrical spinal cord stimulator, which can be used a multiple spinal locations.

Gravity Neutral Device

Intervention Type DEVICE

This device is used to train and assess non-weight bearing stepping movements. When using the device, participants will be lying on their side with their legs suspended off the end of a table supported by small slings that are anchored securely to the apparatus.

Body Weight Supported Treadmill Training

Intervention Type DEVICE

Participants will be supported by a special harness while they are stepping on a treadmill. Trained technicians or therapists will be assist the trunk and legs during stepping as needed.

Complete Spinal Cord Injury - Exoskeleton Assisted Stepping

Group 2 will begin with a 3-month preparation phase and up to 12 sessions in the Ekso device stepping overground. Next, participants will enter Intervention Phase 1 where they will receive training sessions 3 days/week for approximately 2 hours in the Ekso overground, in the presence of stimulation and Buspirone/placebo. The second phase will include the same training procedures except for the removal of Buspirone/placebo administration. The third phase will include sessions twice per week in the Ekso overground with stimulation and one day per week using a rolling walker with stimulation. The last phase will include 2 sessions per week using the rolling walker and one day per week in the Ekso, both in the presence of stimulation and Buspirone/placebo.

Group Type EXPERIMENTAL

Buspirone

Intervention Type DRUG

Oral Buspirone 7.5mg - 10mg daily during the treatment phase.

Non-invasive Spinal Cord Stimulation

Intervention Type DEVICE

A non-invasive transcutaneous electrical spinal cord stimulator, which can be used a multiple spinal locations.

Ekso Bionics Exoskeleton

Intervention Type DEVICE

This robotic exoskeleton is designed to assist people with neurological injuries for balance, standing, and stepping overground.

Rolling Walker

Intervention Type DEVICE

A standard rolling walker will be used for balance support and stability during stepping overground.

Incomplete Spinal Cord Injury - Overground Stepping

Group 3 will begin with a 3-month preparation phase and up to 12 sessions in the Ekso device stepping overground. Next, participants will enter Intervention Phase 1 where they will receive training sessions 3 days/week for approximately 2 hours. The first hour will be done in the Ekso overground and the second hour will use the rolling walker overground, both in the presence of stimulation. Afterwards, the second phase will include the same training procedures with the addition of Buspirone/placebo.

Group Type EXPERIMENTAL

Buspirone

Intervention Type DRUG

Oral Buspirone 7.5mg - 10mg daily during the treatment phase.

Non-invasive Spinal Cord Stimulation

Intervention Type DEVICE

A non-invasive transcutaneous electrical spinal cord stimulator, which can be used a multiple spinal locations.

Ekso Bionics Exoskeleton

Intervention Type DEVICE

This robotic exoskeleton is designed to assist people with neurological injuries for balance, standing, and stepping overground.

Rolling Walker

Intervention Type DEVICE

A standard rolling walker will be used for balance support and stability during stepping overground.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Buspirone

Oral Buspirone 7.5mg - 10mg daily during the treatment phase.

Intervention Type DRUG

Non-invasive Spinal Cord Stimulation

A non-invasive transcutaneous electrical spinal cord stimulator, which can be used a multiple spinal locations.

Intervention Type DEVICE

Ekso Bionics Exoskeleton

This robotic exoskeleton is designed to assist people with neurological injuries for balance, standing, and stepping overground.

Intervention Type DEVICE

Gravity Neutral Device

This device is used to train and assess non-weight bearing stepping movements. When using the device, participants will be lying on their side with their legs suspended off the end of a table supported by small slings that are anchored securely to the apparatus.

Intervention Type DEVICE

Body Weight Supported Treadmill Training

Participants will be supported by a special harness while they are stepping on a treadmill. Trained technicians or therapists will be assist the trunk and legs during stepping as needed.

Intervention Type DEVICE

Rolling Walker

A standard rolling walker will be used for balance support and stability during stepping overground.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Buspar

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Ages 18-65 years old;
2. Stable medical condition;
3. More than 12 month's post injury;
4. Non-progressive spinal cord injury, AIS grade of A, B or C;
5. Neurological level of injury below T1 and above T8;
6. Not taking anti-spasticity medications;
7. Presence of active spinally evoked responses over the lumbo-sacral spinal cord using spinal stimulation;
8. Discontinuation of monoamine oxidase inhibitor (if applicable) for at least 2 weeks prior to initiation of treatment with buspirone.

Exclusion Criteria

1. Active pressure sores;
2. Unhealed bone fractures;
3. Untreated active urinary tract infections;
4. Peripheral neuropathies;
5. Seizure disorders;
6. Cardiopulmonary disease unrelated to spinal cord injury;
7. Anemia;
8. Painful musculoskeletal dysfunction;
9. Contractures in the lower extremities;
10. Lower extremity hardware implantation;
11. Lower extremity lower motor neuron injury;
12. Previous unhealed lower extremity musculoskeletal injuries or disorders, prior to or in conjunction with spinal cord injury;
13. Ventilator dependency;
14. Pregnancy or nursing;
15. Healing wounds/surgical sites along the spine, levels T9-L5;
16. Anti-spasticity implantable pumps;
17. Clinically significant depression, psychiatric disorders, or ongoing drug abuse;
18. Implantable suprapubic catheters;
19. Individuals who are unable to support themselves and/or have difficulty standing;
20. Individuals with abnormal blood panel results related to hepatic function. Up to 10 ml of venous blood will be obtained for the testing;
21. Individuals with increased Creatinine Clearance (Clcr) levels above the normal range;
22. Individuals who are taking drug(s) that interact(s) with Buspirone (BuSpar): Monoamine oxidase inhibitors (MAOIs) - Selegiline (Emsam), Isocarboxazid (Marplan), Phenelzine (Nardil), and Tranylcypromine (Parnate) /these medications must discontinue for at least 2 weeks prior to initiating treatment with Buspirone/; Selective serotonin reuptake inhibitors (SSRIs) - Nefazodone (Serzone) and Trazodone (Oleptro); the blood thinner - Warfarin (Coumadin); Unti-seizure drugs: Phenytoin (Dilantin) and Carbamazepine (Tegretol); Benzodiazepines - Diazepam (Valium) and Triazolam (Halcion); Muscle relaxant - Cyclobenzaprine (Flexeril); Anti-fungal drugs - Itraconazole (Sporanox, Onmel), Itraconazole (Sporanox), and Ketoconazole (Nizoral); Antibiotics - Erythromycin (E.E.S., E-Mycin, Erythrocin) and Rifampin (Rifadin, Rimactane); Steroids (Prednisone and others); Anti-HIV drug - Ritonavir (Norvir); Anti-hypertensive drugs - Diltiazem (Cardizem) and Verapamil (Calan, Verelan, Covera-HS); Anti-psychotic drug - Haloperidol (Haldol);
23. Uncontrolled autonomic dysreflexia;
24. Osteoporosis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No