Clinical trial NCT06274021: Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury
Official title: Shared and Distinct Antispastic Effects of Electrical and Pharmacological Neuromodulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Spinal Cord Injuries
Spinal Cord Injury
Spinal Cord Injury Cervical
Spinal Cord Injury Thoracic
Keywords: Spinal Cord Injury
Neuromodulation
Electrical Stimulation
Spinal Cord Stimulation
Spasticity
Transcutaneous Spinal Stimulation
Lower extremity
Transcutaneous spinal cord stimulation
Paralysis
Spinal reflex
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Methodist Rehabilitation Center
name: The Craig H. Neilsen Foundation
First posted: 2024-02-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: This study employs a crossover design, wherein each participant is systematically administered a sequence of five distinct interventions randomly. This approach ensures that every participant receives each intervention in a unique sequence. The design facilitates within-subject comparisons by minimizing inter-individual variability, as each participant effectively serves as their own control across the study phases. The random assignment of intervention sequences aims to balance potential carryover effects and period effects.
Primary purpose: OTHER

Brief summary: People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Transcutaneous spinal stimulation is a non-surgical intervention by applying electrical currents using skin electrodes over the lower back and belly.

The investigators want to see how well the intervention of transcutaneous spinal stimulation performs by testing different levels of stimulation pulse rates. Also, transcutaneous spinal stimulation is compared to muscle relaxants such as baclofen and tizanidine, commonly given to people with spinal cord injuries, to reduce muscle stiffness and spasms. By doing this, the investigators hope to discover if transcutaneous spinal stimulation similarly reduces muscle spasms and stiffness or if combining both methods works best. This could help improve treatment options for people with spinal cord injuries in the future.

Detailed description: The primary questions to be addressed are whether the intervention reduces muscle stiffness and spasms and alters spinal reflexes:

* Using a 100-Hz (a measure of frequency) transcutaneous spinal stimulation is better than using a 50-Hz.
* Transcutaneous spinal stimulation at 50 Hz differs from a single dose of baclofen.
* Transcutaneous spinal stimulation at 50 Hz differs from a single dose of tizanidine.
* Combining the 50 Hz stimulation with either baclofen or tizanidine decreases spasticity more than just taking the medicine alone.

Participants will visit the Methodist Rehabilitation Center in Jackson, Mississippi, six times over a period of 3 to 5 weeks. During the first visit, the overall health and motor and sensory functions will be assessed following a spinal cord injury. For the next five visits, participants will take a study medication (tizanidine, baclofen, or a placebo). After an hour, they will receive a continuous 30-minute transcutaneous spinal stimulation at either 50 Hz, 100 Hz, or sham. The spinal reflexes and clinical assessments will be evaluated before, during, and after each intervention.

Eligibility criteria: Inclusion criteria:

* Age 18 years or older
* History of spinal cord injury
* Time since diagnosis longer than six months
* Presence of spasticity in the lower limbs (≥ 3 on the Numerical Rating Scale of Spasticity Severity \[range from 0 to 10\])
* If needed, agreement to reduce antispastic medication

Exclusion criteria:

* Neurological level of spinal cord injury below T11
* Ventilatory-dependent
* Change in neurological status over the past 2 months
* Rigidity, contraction, or passive range of motion of less than 40 deg in both knee joints
* Botulinum toxin injections in lower extremities in the previous 3 months before enrollment
* Systolic blood pressure at rest lower than 90 mm Hg
* Implanted active devices (e.g., intrathecal baclofen pumps)
* Passive implants (plates, screws) between T11 and L2 vertebras
* Skin conditions precluding placement of electrodes
* Pressure ulcers stage 2 or higher on the gluteal area or lower extremities
* Receiving antibiotics for infections
* Pregnancy
* Difficulty following instructions
* Participation in another study with investigational drugs or devices within the 30 days preceding and during the present study
* Other medical risks/contraindications as determined by the study physicians

Primary outcomes:
measure: Change from baseline of posterior root reflexes (PRRs) recruitment curves.
timeFrame: Baseline and at post-intervention (100 minutes)
measure: Change from baseline of flexion withdrawal reflex (FWR) response amplitude.
timeFrame: Baseline and at post-intervention (100 minutes)
measure: Change from baseline of stretch reflex (SR) response amplitude.
timeFrame: Baseline and at post-intervention (100 minutes)
measure: Change from baseline in muscle stiffness as measured by the Modified Ashworth Scale (MAS),
timeFrame: Baseline and at post-intervention (100 minutes)
measure: Change from baseline in spasms as measured by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS).
timeFrame: Baseline and at post-intervention (100 minutes)
Secondary outcomes:
measure: Change from baseline of posterior root reflexes (PRRs) recruitment curves.
timeFrame: Baseline and at during transcutaneous spinal stimulation (80 minutes)
measure: Change from baseline of flexion withdrawal reflex (FWR) response amplitude.
timeFrame: Baseline and at during transcutaneous spinal stimulation (80 minutes)
measure: Change from baseline of stretch reflex (SR) response amplitude.
timeFrame: Baseline and at during transcutaneous spinal stimulation (80 minutes)
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, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: