Transcutaneous Spinal Cord Stimulation and Robotic Therapy

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-04-10

Brief Summary

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Lumbosacral spinal stimulation activates the neural network involved in the control of locomotion at the spinal level. However, its effects are limited to the production of robust rhythmic patterns of alternating movement, being currently in the absence of therapeutic value. On the other hand, the use of robotic technology for gait rehabilitation has experienced significant growth during the last years and its clinical efficacy is similar to others traditional interventions.

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Detailed Description

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Spinal cord injury (SCI) often results in complete or partial paralysis below the level of lesion, having a profound physical, psychological and socioeconomic impact on the affected person's life. Between the different approaches for the rehabilitation of SCI, we can find robot therapy. Robot-assisted gait training has emerged as a promising therapy for improving walking ability, balance and motor function in neurological patients. The underlying principle of this therapy is based on the execution of repetitive and task-specific training able to generate appropriate afferent inputs, activating the central pattern generators in the lumbosacral spinal cord. Another novel therapy is the use of transcutaneous spinal cord stimulation (tSCS), applied through self-adhesive electrodes in the skin. tSCS activates similar mechanisms than epidural stimulation and is able to stimulate the spinal locomotor circuits in SCI patients. It allows the activation of rhythmic, flexo-extension movements in the paralyzed lower limbs.

The aim of this study is to analyze the feasibility, safety and efectiveness of a program of 20 sessions of 30 Hz-tSCS applied over T11-12 intervertebral space combined with Lokomat training in patients with incomplete SCI.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is a double-blind, randomized, controlled clinical trial.

There will be two groups:

Group A (n=15): tSCS combined with Lokomat Group B (n=15): Sham-tSCS combined with Lokomat

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

For blinding of participants:

The protocol will be the same in the active tSCS and sham tSCS groups. The sham stimulation will consist of the same stimulation parameters used for active tSCS, except for the stimulus intensity, which will be set at the sensory threshold, maintained for 30 s and then slowly decreased to zero. The participants will receive the same instructions that given to the active tSCS session.

For blinding of outcomes assessor:

Two blinded assessors will perform the evaluations before, after and a follow-up at 4 weeks post-intervention.

The operator of the Lokomat will be also masked to the group allocation. To ensure this, the same stimulator and electrode location will be used for both groups and the screen of the device will be covered. Only the investigator who applies spinal stimulation will know which group belongs the patient.

Study Groups

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Active tSCS and Lokomat

20 sessions, 5 sessions per week of active transcutaneous spinal cord stimulation (tSCS) combined with Lokomat will be performed.

The duration of Lokomat will be 30 minutes, of which the first 20 minutes tSCS will be applied at the beginning of each session.

Group Type ACTIVE_COMPARATOR

Active tSCS and Lokomat

Intervention Type DEVICE

A symmetrical biphasic 30 Hz current of 1 ms pulse-width with an electro-stimulator will be applied.

For the stimulation intensity, the maximum intensity tolerated by the patient will be selected. The intensity will be increased in case of habituation to the current.

Sham tSCS and Lokomat

20 sessions, 5 sessions per week of sham transcutaneous spinal cord stimulation (sham-tSCS) combined with Lokomat will be performed.

The duration of Lokomat will be 30 minutes, of which the first 20 minutes sham-tSCS will be applied at the beginning of each session.

Group Type PLACEBO_COMPARATOR

Sham tSCS and Lokomat

Intervention Type DEVICE

The protocol and device of sham tSCS combined with Lokomat will be the same as active tSCS except for the stimulus intensity, which will be set at the sensory threshold, maintained for 30 seconds and then slowly will be decreased to zero, being this intensity maintained for the remaining 20 minutes of stimulation.

Interventions

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Active tSCS and Lokomat

A symmetrical biphasic 30 Hz current of 1 ms pulse-width with an electro-stimulator will be applied.

For the stimulation intensity, the maximum intensity tolerated by the patient will be selected. The intensity will be increased in case of habituation to the current.

Intervention Type DEVICE

Sham tSCS and Lokomat

The protocol and device of sham tSCS combined with Lokomat will be the same as active tSCS except for the stimulus intensity, which will be set at the sensory threshold, maintained for 30 seconds and then slowly will be decreased to zero, being this intensity maintained for the remaining 20 minutes of stimulation.

Intervention Type DEVICE

Other Intervention Names

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Experimental Controlled

Eligibility Criteria

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Inclusion Criteria

* AIS C or D.
* 2-6 months after injury.
* Neurological level of injury between C4-T11.
* Ashworth less or equal 2.
* Penn less or equal 2.
* To understand and to sign the informed consent.

Exclusion Criteria

* Metal implants over T11-T12
* Electronic device implants.
* Epilepsy
* Allergy to the electrode material
* Pregnancy
* Concomitant pathologies
* Pathology or fracture of the lower limbs
* Musculoskeletal injury in the lower limbs
* Lower limbs dysmetria

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No