Clinical trial NCT05457205: Transcutaneous Spinal Stimulation for Lower Limb Spasticity in Spinal Cord Injury
Official title: Transcutaneous Spinal Stimulation for Reducing Lower Limb Spasticity in Chronic Spinal Cord Injury: a Cross-over Study of Immediate Effects and Outcomes of Home-based Therapy Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Spasticity, Muscle
Keywords: Transcutaneous Spinal Cord Stimulation
Neuromodulation
Electrical Stimulation
Spasticity
Lower Extremities
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Methodist Rehabilitation Center
First posted: 2022-07-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Spasticity develops months after spinal cord injury (SCI) and persists over time. It presents as a mixture of tonic features, namely increased muscle tone (hypertonia) and phasic features, such as hyperactive reflexes (hyperreflexia), clonus, and involuntary muscle contractions (spasms). Spasticity is often disabling because it interferes with hygiene, transfers, and locomotion and can disturb sleep and cause pain. For these reasons, most individuals seek treatments for spasticity after SCI. New developments in electrical neuromodulation with transcutaneous spinal stimulation (TSS) show promising results in managing spasticity non-pharmacologically. The underlying principle of TSS interventions is that the afferent input generated by posterior root stimulation modifies the excitability of the lumbosacral network to suppress pathophysiologic spinal motor output contributing to distinctive features of spasticity. However, the previous TSS studies used almost identical protocols in terms of stimulation frequency and intensity despite the great flexibility offered by this treatment strategy and the favorable results with the epidural stimulation at higher frequencies. Therefore, the proposed study takes a new direction to systematically investigate the standalone and comparative efficacy of four TSS interventions, including those used in previous studies.

Our central hypothesis is that electrical neuromodulation with the selected TSS protocols (frequency: 50/100 Hz; intensity: 0.45 or 0.9 times the sub-motor threshold) can reduce and distinctly modify tonic and phasic components of spasticity on short- and long-term basis. We will test our hypothesis using a prospective, experimental, cross-over, assessor-masked study design in 12 individuals with chronic SCI (more than 1-year post-injury).

Aim 1. Determine the time course of changes and immediate after-effects of each TSS protocol on tonic and phasic spasticity. The results will reveal the evolution of changes in spasticity during 30-min of TSS and the most effective protocol for producing immediate aftereffects.

Aim 2. Determine the effect of TSS on spasticity after a trial of home-based therapy with each protocol. The participants will administer 30 min of TSS daily for six days with each of the four TSS protocols selected randomly. This aim will reveal the long-term carry-over effects of TSS intervention on various components of spasticity after SCI.

Aim 3. Determine the participants' experience with TSS as a home-based therapy through focus group meetings. We will conduct focus group meetings after participants finish the home-based therapy trial. Accomplishing this specific aim will provide a valuable perspective on the value, challenges, and acceptability of TSS as a home-based intervention.

The study addresses important questions for advancing scientific knowledge and clinical management of spasticity after SCI. Specifically, it will examine the efficacy of TSS frequencies and intensities on tonic and phasic spasticity. The study results will be relevant for a high proportion of individuals living with SCI that could benefit from this novel and low-cost non-pharmacological approach to managing spasticity after SCI.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* History of SCI (ASIA Impairment Scale grades A-D)
* Time since injury longer than 6 months
* The presence of at least mild spasticity (\>3) in the lower limbs by self-report of the Numerical Rating Scale (from 0 to 10) of spasticity severity
* Signed consent form

Exclusion Criteria:

* Neurological level of SCI below T11
* Suspected progression of SCI (e.g., syringomyelia)
* Ventilatory-dependent
* Implanted active devices (e.g., intrathecal baclofen pumps)
* Passive implants (plates, screws) between T10 and L3 vertebras
* Skin conditions precluding placement of electrodes
* Ongoing infections
* Pregnancy
* Difficulty following instructions
* No access to a caregiver/family member to help with electrode placement at home
* Other medical risks/contraindications as determined by the study physicians

Primary outcomes:
measure: Change in posterior root reflex amplitude
timeFrame: Before and after an intervention session (30 minutes)
measure: Change in posterior root reflex amplitude (during intervention)
timeFrame: Before and during an intervention session (15 minutes)
measure: Change in flexion withdrawal reflex root-mean-square
timeFrame: Before and after an intervention session (30 minutes)
measure: Change in flexion withdrawal reflex root-mean-square (during intervention)
timeFrame: Before and during an intervention session (15 minutes)
measure: Change in pendulum test index
timeFrame: Before and after an intervention session (30 minutes)
measure: Change in pendulum test index (during intervention)
timeFrame: Before and during an intervention session (15 minutes)
Secondary outcomes:
measure: Change in Modified Ashworth Scale
timeFrame: Before and after an intervention session (30 minutes)
measure: Change in Modified Ashworth Scale (after one week)
timeFrame: Before and after one week
measure: Change in Spinal Cord Assessment Tool for Spastic Reflexes
timeFrame: Before and after an intervention session (30 minutes)
measure: Change in Spinal Cord Assessment Tool for Spastic Reflexes (after one week)
timeFrame: Before and after one week
measure: Change in Penn Spasm Frequency Scale
timeFrame: Before and after an intervention session (30 minutes)
measure: Change in Penn Spasm Frequency Scale (after one week)
timeFrame: Before and after one week
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Methodist Rehabilitation Center
state: Mississippi
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Matthias J Krenn, PhD
role: PRINCIPAL_INVESTIGATOR
References: