Exoskeleton + Spinal Cord Stimulation for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Overseen by Gail F Forrest, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kessler Foundation

Disqualifiers: Bone fractures, Bone trauma, Bone disease

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The overall aim of this project is to assess the effect of combining transcutaneous lumbosacral stimulation (TLS) during Exoskeleton Assisted Walking (EAW) compared to EAW alone without stimulation on walking recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Exoskeleton-Assisted Walking and Transcutaneous Lumbosacral Stimulation for Spinal Cord Injury?

Research shows that using exoskeletons like Indego can improve walking speed and independence in people with spinal cord injuries. Combining exoskeleton walk training with spinal cord electrical stimulation (SCES) can enhance foot loading forces and improve neurological scores, suggesting better walking ability and sensation. ^{1 2 3 4 5}

Is the exoskeleton and spinal cord stimulation treatment safe for humans?

Research shows that using powered exoskeletons like Indego and ReWalk for spinal cord injury is generally safe, with only minor issues like skin irritations reported. Participants in studies were able to use the devices without major problems, and no serious adverse events were noted. ^{2 5 6 7 8}

How does Exoskeleton-Assisted Walking with Spinal Cord Stimulation differ from other treatments for spinal cord injury?

This treatment is unique because it combines wearable exoskeleton technology with spinal cord electrical stimulation to enhance walking ability and motor recovery in individuals with spinal cord injury. The combination aims to activate locomotor networks and improve compensative sensitivity, offering potential benefits over exoskeleton use alone. ^{2 3 4 5 9}

Research Team

Gail F Forrest, PhD

Principal Investigator

Kessler Foundation

Eligibility Criteria

This trial is for adults aged 21-58 who are wheelchair reliant due to a spinal cord injury (SCI) that occurred over 6 years ago. Participants must be between 62 and 74 inches tall, have some lower limb movement, and no history of bone fractures or diseases.

Inclusion Criteria

My spinal cord injury is between my neck and mid-back.

I use a wheelchair all the time.

I am between 21 and 58 years old.

Exclusion Criteria

I have had bone disease or injury in the past.

I have had broken bones in the past.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Initial evaluation including stand evaluation and instruction in proper use of the exoskeleton device

1 week

1 visit (in-person)

Treatment

Participants receive 60 minutes of exoskeleton-assisted walking with or without TLS for 80 sessions over 28 weeks

28 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for changes in walking ability, balance, and other health metrics

4 weeks

Treatment Details

Interventions

• Exoskeleton-Assisted Walking (Procedure)
• Transcutaneous Lumbosacral Stimulation (TLS) (Spinal Cord Stimulation)

Trial Overview The study is testing if using transcutaneous lumbosacral stimulation (TLS) while walking with an exoskeleton helps improve walking ability in people with SCI compared to just using the exoskeleton alone.

Participant Groups

Group I: EAW without TLS Experimental Treatment 1 Intervention

EAW, exoskeleton-assisted walking, an activity based therapy is a training which involves using the same exoskeleton device for all the participants. Each participant will undergo, 60 minutes of EAW as above. Each participant will undergo a stand evaluation and be instructed in proper use of the device. During the initial 3 sessions of training, the exoskeleton device will be tethered to an overhead pulley system during training to allow subjects to safely adapt to trunk, balance gait activities while walking in the exoskeleton. EAW overground walking will follow each training session with the 6-minute walk test, 10 meter walk test .

Group II: EAW + TLS Experimental Treatment 2 Interventions

The EAW+TLS training group will receive 60 minutes of exoskeleton-assisted walking overground per session, for a total of 80 sessions (3x/week, 28 wks.) with simultaneous transcutaneous lumbosacral stimulation (TLS) intervention followed by 15 minutes of over ground training without the exoskeleton. component is added to the exoskeleton assisted walking component in this group. TLS will involve placing self-adhesive stimulating electrodes bilaterally over the T11/T12 lumbar region. Correct placement will be confirmed by the elicitation of posterior root muscle reflexes in the lower limb muscles. A constant-voltage stimulator (RT 50 Sage stimulator) will deliver pulses of 2 ms width. TLS will be applied while the participant walks in the Exo-skeleton-assisted walking (EAW).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Kessler Foundation West Orange, NJ

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Patients Recruited

11,300+

Kessler Institute for Rehabilitation

Industry Sponsor

Trials

23

Patients Recruited

1,100+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exoskeletal-Assisted Walking During Acute Inpatient Rehabilitation Leads to Motor and Functional Improvement in Persons With Spinal Cord Injury: A Pilot Study. Tsai, CY., Delgado, AD., Weinrauch, WJ., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Outcomes from a Multicenter Study Utilizing the Indego Powered Exoskeleton in Spinal Cord Injury. Tefertiller, C., Hays, K., Jones, J., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exoskeleton Walk Training in Paralyzed Individuals Benefits From Transcutaneous Lumbar Cord Tonic Electrical Stimulation. Shapkova, EY., Pismennaya, EV., Emelyannikov, DV., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voluntary driven exoskeleton as a new tool for rehabilitation in chronic spinal cord injury: a pilot study. Aach, M., Cruciger, O., Sczesny-Kaiser, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness and Safety of Exoskeletons as Assistive and Rehabilitation Devices in the Treatment of Neurologic Gait Disorders in Patients with Spinal Cord Injury: A Systematic Review. Fisahn, C., Aach, M., Jansen, O., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis. Miller, LE., Zimmermann, AK., Herbert, WG.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerance of the ReWalk™ exoskeleton suit for ambulation by people with complete spinal cord injury: a pilot study. Zeilig, G., Weingarden, H., Zwecker, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device-Training for Individuals with Thoracic and Lumbar Spinal Cord Injury Using a Powered Exoskeleton for Technically Assisted Mobility: Achievements and User Satisfaction. Platz, T., Gillner, A., Borgwaldt, N., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the determinants of implementation of a locomotor training program using a powered exoskeleton for individuals with a spinal cord injury. Charette, C., Déry, J., Blanchette, AK., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Exoskeletal-Assisted Walking During Acute Inpatient Rehabilitation Leads to Motor and Functional Improvement in Persons With Spinal Cord Injury: A Pilot Study. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Initial Outcomes from a Multicenter Study Utilizing the Indego Powered Exoskeleton in Spinal Cord Injury. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Exoskeleton Walk Training in Paralyzed Individuals Benefits From Transcutaneous Lumbar Cord Tonic Electrical Stimulation. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Voluntary driven exoskeleton as a new tool for rehabilitation in chronic spinal cord injury: a pilot study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The Effectiveness and Safety of Exoskeletons as Assistive and Rehabilitation Devices in the Treatment of Neurologic Gait Disorders in Patients with Spinal Cord Injury: A Systematic Review. [2020]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Safety and tolerance of the ReWalk™ exoskeleton suit for ambulation by people with complete spinal cord injury: a pilot study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Device-Training for Individuals with Thoracic and Lumbar Spinal Cord Injury Using a Powered Exoskeleton for Technically Assisted Mobility: Achievements and User Satisfaction. [2018]

9. England pubmed.ncbi.nlm.nih.gov

A systematic review of the determinants of implementation of a locomotor training program using a powered exoskeleton for individuals with a spinal cord injury. [2023]