Transcutaneous Electrical Stimulation for Stroke Patients

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

RECRUITING

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-18

Study Completion Date

2027-01-01

Brief Summary

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This study aims to evaluate the feasibility and impact of transcutaneous electrical stimulation of the spinal cord (TESS) on the recovery of post-stroke individuals who have upper limb hemiparesis. It will compare outcomes measures between individuals who receive upper limb task specific training with TESS and individuals who receive task specific training of the upper limb with Sham, or fake, TESS.

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Detailed Description

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Upper limb (UL) hemiparesis is the most common post-stroke disability. Currently, there is no treatment used in the clinic that has shown to be efficacious for 75% of individuals who have moderate to severe UL hemiparesis. There are no interventions for individuals with moderate to severe hemiparesis that have demonstrated superiority in comparison to standard care. These stroke patients often have increased spasticity and muscle weakness, resulting in chronic upper limb dysfunction. We are proposing an alternative strategy to improve upper limb function after stroke: transcutaneous electrical stimulation of the spinal cord (TESS). Our objective is to evaluate the feasibility and neural effects of transcutaneous spinal stimulation plus task specific training in a two-arm study with three time points (pre-/post-intervention and follow-up). We will recruit 14 chronic post-stroke participants who will receive 15 sessions of either TESS plus task specific training or Sham TESS plus task specific training. Our long-term research goal is to use TESS as a therapeutic strategy, combined with task specific training, to improve upper limb impairment and function in chronic stroke survivors. Our central hypothesis is that excitation of spinal circuitry by spinal stimulation will result in more effective motor control that will improve volitional upper limb movement (as compared to sham stimulation plus task specific training). This hypothesis is based on published work in cervical spinal cord injury.

Conditions

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Upper Limb Hemiparesis Following Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This interventional study uses a randomized, single-blind (evaluator masked), parallel, two-arm experimental design with an appropriate active comparator.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

During treatment sessions, both the experimental group and the active comparator group receive the same task specific training protocol as well as don the TESS system. For the active comparator group, the TESS will be turned on to a threshold level of sensation. The participant will be told that the stimulation is being lowered to a below-threshold level, at which point it will be turned off for the rest of the session. This will allow the participants to remain blinded. It is not possible to perform the protocol with blinded treatment therapists. The blinded evaluator is not present during the treatment sessions and will not be told which group the participant is in.

Study Groups

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Experimental Group

This group receives task specific training and transcutaneous spinal cord stimulation (TESS) during treatment sessions. TESS is applied via electrodes placed vertically over the spinous processes of C5-C6. The stimulation will be adjusted within a range of 10mA to 100mA based on participant tolerance and will be delivered for 30 minutes per training session.

Group Type ACTIVE_COMPARATOR

Task Specific Training (TST)

Intervention Type OTHER

Task specific training activities are types of activities that may be used in standard of care for stroke rehabilitation. Tasks will be completed in sitting or standing. As is usual in studies for upper limb hemiparesis, study participants will be picking up objects with their affected hands. They will work on grasp, grasp-lift of objects, release of objects, reaching and grasping, and reaching without grasping.

Transcutaneous electrical spinal cord stimulation (TESS)

Intervention Type OTHER

The Digitimer DS8R Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation. The stimulus intensity used during the intervention will be determined based on individual maximum tolerance. We expect this current amplitude to be between 10mA and 100mA. Stimulation time will be standardized to a 30min duration during which the participant will perform task specific training tasks.

Comparator Group

This group receives task specific training without real TESS during treatment sessions. Instead, they receive Sham TESS, which is a placebo version in which the electrodes are applied and the stimulation is turned on so that the patient can feel it, and then ramped down to zero for the duration of the session.

Group Type ACTIVE_COMPARATOR

Task Specific Training (TST)

Intervention Type OTHER

Task specific training activities are types of activities that may be used in standard of care for stroke rehabilitation. Tasks will be completed in sitting or standing. As is usual in studies for upper limb hemiparesis, study participants will be picking up objects with their affected hands. They will work on grasp, grasp-lift of objects, release of objects, reaching and grasping, and reaching without grasping.

Sham transcutaneous electrical spinal cord stimulation (Sham TESS)

Intervention Type OTHER

The Sham TESS intervention will utilize the same device and setup as the true TESS intervention. However, after turning on the stimulation and reaching the appropriate intensity, the stimulation will be ramped down and turned off for the remainder of the treatment session. The participant will be told that the stimulation was brought down to a sub-threshold level in order to maintain treatment group blinding.

Interventions

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Task Specific Training (TST)

Task specific training activities are types of activities that may be used in standard of care for stroke rehabilitation. Tasks will be completed in sitting or standing. As is usual in studies for upper limb hemiparesis, study participants will be picking up objects with their affected hands. They will work on grasp, grasp-lift of objects, release of objects, reaching and grasping, and reaching without grasping.

Intervention Type OTHER

Transcutaneous electrical spinal cord stimulation (TESS)

The Digitimer DS8R Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation. The stimulus intensity used during the intervention will be determined based on individual maximum tolerance. We expect this current amplitude to be between 10mA and 100mA. Stimulation time will be standardized to a 30min duration during which the participant will perform task specific training tasks.

Intervention Type OTHER

Sham transcutaneous electrical spinal cord stimulation (Sham TESS)

The Sham TESS intervention will utilize the same device and setup as the true TESS intervention. However, after turning on the stimulation and reaching the appropriate intensity, the stimulation will be ramped down and turned off for the remainder of the treatment session. The participant will be told that the stimulation was brought down to a sub-threshold level in order to maintain treatment group blinding.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* able and willing to give written consent and comply with study procedures
* at least 6 months post-stroke
* hemiplegia secondary to stroke
* UE Fugle Meyer Assessment \<35
* not currently receiving regular occupational therapy services
* participant has received clearance from physician to participate in study
* participant has at least a rudimentary comprehension of English

Exclusion Criteria

* botox injection in upper extremity within the last 4 months
* modified ashworth score of 4 in any joint of the affected limb
* pregnant or nursing
* using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD), or anti-spasticity implantable pumps, or cochlear implants
* unhealed bone fractures
* severe contractures in the upper extremities
* active cancer or cancer remission less than 5 years
* orthopedic dysfunction, injury, or surgery that would impact the individual's ability to use the upper extremities
* recent procedure or operation of the spinal cord within the past year
* traumatic brain injury or neurological conditions that would impact the study
* skull fracture that has developed within the past 6 months
* non-English speakers

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No