18 Participants Needed

Spinal Cord Stimulation for Spinal Cord Injury

HS
EF
Overseen ByEmily Fox, PT, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Locomotor training (LT) facilitates recovery of spinal locomotor networks after incomplete spinal cord injury (ISCI), but walking impairments persist. A limitation of LT is insufficient excitation of spinal locomotor circuits to induce neuroplastic recovery. Transcutaneous spinal direct current stimulation (tsDCS) is a non-invasive approach to increase spinal excitation and modulate spinal reflexes. The study will examine if tsDCS combined with LT enhances locomotor rehabilitation after ISCI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for spinal cord injury?

Research shows that transcutaneous spinal direct current stimulation (tsDCS) can modulate spinal cord activity and improve certain functions in people with incomplete spinal cord injury, such as walking ability and muscle control. Additionally, tsDCS has been shown to affect pain pathways and spinal excitability, which may contribute to its effectiveness.12345

Is transcutaneous spinal direct current stimulation (tsDCS) safe for humans?

Research indicates that transcutaneous spinal direct current stimulation (tsDCS) is a safe technique for modulating spinal cord excitability in humans.12346

How is the treatment tsDCS unique for spinal cord injury?

Transcutaneous spinal direct current stimulation (tsDCS) is unique because it is a non-invasive treatment that uses weak electrical currents to stimulate the spinal cord, potentially improving movement and reducing spasticity in people with spinal cord injuries. Unlike other treatments, tsDCS can modulate spinal cord excitability and pain pathways without the need for surgery or medication.12345

Research Team

EF

Emily Fox, DPT, PhD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for adults aged 18-65 with a chronic spinal cord injury at T12 or above, who can walk 3 meters with assistance. They must be medically stable and able to consent. Excluded are those with skin wounds, severe spasticity, pregnancy, unstable conditions like heart disease, cognitive impairments, other neurological disorders, joint contractures that limit walking ability, visual impairment preventing safe participation in rehabilitation activities.

Inclusion Criteria

I am between 18 and 65 years old.
Ability to provide informed consent
Medical stability with clearance from physician
See 2 more

Exclusion Criteria

I am currently in a program to improve my walking.
My pain restricts my ability to walk or join in walking rehab.
I am legally blind or have severe vision problems.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 20 sessions of transcutaneous spinal direct current stimulation (tsDCS) combined with locomotor training (LT) over 5 weeks

5 weeks
20 visits (in-person)

Post-intervention Assessment

Clinical assessments of walking function and reflex testing are completed one to three days post-intervention

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment with a follow-up assessment of walking and mobility function

2 weeks
1 visit (in-person)

Treatment Details

Interventions

  • High Dose Intervention-tsDCS
  • Low Dose Intervention-tsDCS
Trial OverviewThe AMPLIFY Study tests whether adding transcutaneous spinal direct current stimulation (tsDCS) to locomotor training helps improve walking after an incomplete spinal cord injury. Participants will receive either a high dose or low dose of tsDCS while undergoing walking rehabilitation exercises.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: High Dose InterventionExperimental Treatment1 Intervention
tsDCS will be delivered to the lumbar region of the spinal cord during LT using a commercially available stimulation unit (Soterix Medical, Inc., New York, NY). tsDCS electrodes are comprised of a 10x5 cm carbon rubber electrode encased in a saline-soaked sponge. The anode electrode will be placed on the skin over the spinal processes of the 11th and 12th thoracic vertebrae, and the two cathode electrodes will be placed on each side of the umbilicus. For the high dose group, a standard dosage of 30 continuous minutes of 2.5 mA stimulus will be used.
Group II: Low Dose InterventionActive Control1 Intervention
tsDCS will be delivered to the lumbar region of the spinal cord during LT using a commercially available stimulation unit (Soterix Medical, Inc., New York, NY). tsDCS electrodes are comprised of a 10x5 cm carbon rubber electrode encased in a saline-soaked sponge. The anode electrode will be placed on the skin over the spinal processes of the 11th and 12th thoracic vertebrae, and the two cathode electrodes will be placed on each side of the umbilicus. The low dose condition will use an identical montage and stimulation arrangement, except the stimulation will be delivered briefly at the beginning and end of the stimulation period (30 seconds) with a three-second ramp.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Brooks Rehabilitation

Collaborator

Trials
16
Recruited
1,900+

The Craig H. Neilsen Foundation

Collaborator

Trials
62
Recruited
3,100+

Findings from Research

Transcutaneous spinal Direct Current Stimulation (tsDCS) can effectively modulate interhemispheric motor connectivity, with anodal stimulation increasing interhemispheric delay and decreasing the duration of the ipsilateral Silent Period, indicating enhanced communication between brain hemispheres.
The study suggests that tsDCS could serve as a promising therapeutic tool for conditions involving impaired interhemispheric balance, offering a safe alternative for rehabilitation in patients with acute brain lesions when other non-invasive brain stimulation techniques may not be suitable.
An unexpected target of spinal direct current stimulation: Interhemispheric connectivity in humans.Bocci, T., Caleo, M., Vannini, B., et al.[2022]
In a double-blinded study involving 2 male patients with incomplete spinal cord injury, anodal transcutaneous spinal direct current stimulation (tsDCS) improved all measured outcomes, including gait and balance, while cathodal tsDCS showed mixed results.
Both types of tsDCS were able to modulate corticospinal excitability, indicating that this non-invasive method could be a promising approach for enhancing rehabilitation in patients with spinal cord injuries.
Spinal direct current stimulation with locomotor training in chronic spinal cord injury.Abualait, TS., Ibrahim, AI.[2021]
Anodal transcutaneous spinal direct current stimulation (tsDCS) significantly increased the temporal summation threshold of the nociceptive withdrawal reflex in 10 healthy subjects, indicating its potential to modulate spinal cord pain pathways.
This stimulation also led to a decrease in the perception of pain, suggesting that anodal tsDCS could be an effective non-invasive treatment for clinical pain conditions related to spinal cord activity.
Modulation of temporal summation threshold of the nociceptive withdrawal reflex by transcutaneous spinal direct current stimulation in humans.Perrotta, A., Bolla, M., Anastasio, MG., et al.[2017]

References

An unexpected target of spinal direct current stimulation: Interhemispheric connectivity in humans. [2022]
Spinal direct current stimulation with locomotor training in chronic spinal cord injury. [2021]
Modulation of temporal summation threshold of the nociceptive withdrawal reflex by transcutaneous spinal direct current stimulation in humans. [2017]
Spinal Direct Current Stimulation Modulates Short Intracortical Inhibition. [2022]
Effects of transcutaneous spinal direct current stimulation in idiopathic restless legs patients. [2018]
Trans-Spinal Direct Current Stimulation in Neurological Disorders: A systematic review. [2023]