SCS for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nandan Lad, M.D., Ph.D.
Disqualifiers: Complete cord transection, Spinal instability, Psychosis, others
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing Spinal Cord Stimulation (SCS) for patients with Spinal Cord Injury (SCI) to manage pain and improve physical functions. The treatment uses electrical pulses to interfere with pain signals and may help with movement and sensation. Patients will receive either active SCS treatment or their usual care. Spinal cord stimulation (SCS) has been used since 1967 and is an evidence-based treatment for various chronic pain disorders, including failed back surgery syndrome (FBSS).
Will I have to stop taking my current medications?
The trial does not specify that you need to stop taking your current medications. In fact, it mentions that all patients will continue receiving conventional medical management, which includes medications.
What data supports the effectiveness of the treatment Spinal Cord Stimulation, Epidural Electrical Stimulation (EES), Transcutaneous Spinal Cord Stimulation (tSCS) for spinal cord injury?
Research shows that transcutaneous spinal cord stimulation (tSCS) can help improve voluntary movement, muscle strength, and function in people with spinal cord injuries. Additionally, spinal cord epidural stimulation (scES) has enabled some patients to regain voluntary movement and even walk again after a spinal cord injury.
12345Is spinal cord stimulation generally safe for humans?
Spinal cord stimulation (SCS) is generally considered a safe treatment for chronic pain conditions, with well-defined complication rates over 40 years of use. However, the risk of spinal cord injury during electrode implantation is not well understood, and the removal of paddle electrodes has risks that are not clearly defined in the literature.
16789How is the treatment Spinal Cord Stimulation (SCS) unique for spinal cord injury?
Spinal Cord Stimulation (SCS), particularly in its transcutaneous form (tSCS), is unique because it is a non-invasive treatment that uses electrical stimulation to activate spinal circuits and improve motor function in individuals with spinal cord injury. Unlike other treatments, it can enhance voluntary movement and muscle strength without surgery, making it a promising option for rehabilitation.
123410Eligibility Criteria
This trial is for adults aged 18-80 with traumatic thoracic spinal cord injury and chronic pain, who can consent to the study and attend required visits. Candidates must be medically stable for SCS implant surgery and rehabilitation but cannot have complete cord transection, untreated major depression, active infection or substance abuse, or be pregnant.Inclusion Criteria
Subjects must be willing and able to provide informed consent, attend required study visits, and complete required assessments/questionnaires
I have been in pain for more than 3 months.
I am between 18 and 80 years old.
+2 more
Exclusion Criteria
Subjects must not have comorbid psychosis or psychotic disorder
Subjects must not have complete cord transection
Subjects must not have active drug or alcohol abuse
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Trial Procedure
Participants undergo a temporary trial procedure of SCS for 5-7 days to assess effectiveness
1 week
1 visit (in-person)
Treatment
Participants receive SCS ON or OFF along with CMM for 3 months. Placebo group may crossover to SCS ON after 3 months.
3 months
Multiple visits (in-person and remote)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with data collection at 1, 3, 6, 12, and 15 months post-implantation
9 months
Multiple visits (in-person and remote)
Participant Groups
The study compares Spinal Cord Stimulation (SCS) plus conventional medical management (CMM) against CMM alone in managing SCI pain and aiding rehabilitation. Participants will either receive SCS turned on or off randomly while continuing CMM like medications and physical therapy for a year.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EES onExperimental Treatment1 Intervention
Patients will undergo epidural electrical stimulation (EES) and be randomized in a 1:1 allocation to EES on. Both the patient and the provider will be formally blinded to treatment assignment. Only the biostatistician and programming team will be unblinded to treatment assignments.
Group II: EES offPlacebo Group1 Intervention
Patients will undergo epidural electrical stimulation (EES) and be randomized in a 1:1 allocation to EES off. Both the patient and the provider will be formally blinded to treatment assignment. Only the biostatistician and programming team will be unblinded to treatment assignments.ES off. Those in the EES off category will have their EES turned on at the 9-month timepoint.
Spinal Cord Stimulation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Spinal Cord Stimulation for:
- Failed back surgery syndrome (FBSS)
- Adhesive arachnoiditis
- Peripheral causalgia/neuropathy
- Reflex sympathetic dystrophy (RSD)
- Phantom limb/stump pain
- Ischemic pain of vascular origin
- Complex regional pain syndrome
- Pain after an amputation
- Visceral abdominal pain and perineal pain
🇪🇺 Approved in European Union as Spinal Cord Stimulation for:
- Chronic pain
- Neuropathic pain
- Spinal cord injury pain
- Failed back surgery syndrome (FBSS)
- Adhesive arachnoiditis
- Peripheral causalgia/neuropathy
- Reflex sympathetic dystrophy (RSD)
🇨🇦 Approved in Canada as Spinal Cord Stimulation for:
- Chronic pain
- Neuropathic pain
- Spinal cord injury pain
- Failed back surgery syndrome (FBSS)
- Adhesive arachnoiditis
- Peripheral causalgia/neuropathy
- Reflex sympathetic dystrophy (RSD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke University Health SystemsDurham, NC
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Who Is Running the Clinical Trial?
Nandan Lad, M.D., Ph.D.Lead Sponsor
References
Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]Transcutaneous spinal cord stimulation (tSCS) is a non-invasive modality in which electrodes can stimulate spinal circuitries and facilitate a motor response. This review aimed to evaluate the methodology of studies using tSCS to generate motor activity in persons with spinal cord injury (SCI) and to appraise the quality of included trials.
Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]Cervical transcutaneous spinal cord stimulation (tSCS) is a rehabilitation tool which has been used to promote upper-limb motor recovery after spinal cord injury. Importantly, optimizing sensory fiber activation at specific spinal segments could enable activity-dependent neuromodulation during rehabilitation.
Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [2022]To evaluate the impact of using transcutaneous electrical spinal cord stimulation (TSCS) on upper and lower extremity function in individuals with chronic spinal cord injury (SCI).
Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. [2021]Background. Epidural spinal electrical stimulation at the lumbar spinal level evokes rhythmic muscle activation of lower-limb antagonists, attributed to the central pattern generator. However, the efficacy of noninvasive spinal stimulation for the activation of lower-limb muscles is not yet clear. This review aimed to analyze the feasibility and efficacy of noninvasive transcutaneous spinal cord stimulation (tSCS) on motor function in individuals with spinal cord injury. Methods. A search for tSCS studies was made of the following databases: PubMed; Cochrane Registry; and Physiotherapy Evidence Database (PEDro). In addition, an inverse manual search of the references cited by the identified articles was carried out. The keywords transcutaneous, non-invasive, electrical stimulation, spinal cord stimulation [Mesh term], and spinal cord injury were used. Results. A total of 352 articles were initially screened, of which 13 studies met the inclusion criteria for systematic review. The total participant sample comprised 55 persons with spinal cord injury. All studies with tSCS provided evidence of induced muscle activation in the lower and upper limbs, and applied stimulation at the level of the T11-T12 and C4-C7 interspinous space, respectively. All studies reported an increase in motor response measured by recording surface electromyography, voluntary movement, muscle strength, or function. Conclusions. Although this review highlights tSCS as a feasible therapeutic neuromodulatory strategy to enhance voluntary movement, muscle strength, and function in patients with chronic spinal cord injury, the clinical impact and efficacy of electrode location and current intensity need to be characterized in statistically powered and controlled clinical trials.
Spinal cord epidural stimulation for motor and autonomic function recovery after chronic spinal cord injury: A case series and technical note. [2023]Label="Background" NlmCategory="UNASSIGNED">Traumatic spinal cord injury (tSCI) is a debilitating condition, leading to chronic morbidity and mortality. In recent peer-reviewed studies, spinal cord epidural stimulation (scES) enabled voluntary movement and return of over-ground walking in a small number of patients with motor complete SCI. Using the most extensive case series (n = 25) for chronic SCI, the present report describes our motor and cardiovascular and functional outcomes, surgical and training complication rates, quality of life (QOL) improvements, and patient satisfaction results after scES.
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]Spinal cord stimulation (SCS) is a safe, reversible surgical treatment for complex regional pain syndrome and failed back surgery syndrome refractory to conventional medical management. Paddle electrodes are routinely used for the permanent implant because of the reduced risk of migration, lower energy requirements, and expanded coverage options. The risks associated with paddle lead removal are not well defined in the literature.
Incidence and avoidance of neurologic complications with paddle type spinal cord stimulation leads. [2022]While reference is frequently made to the risk of spinal cord or nerve root injury with the surgical implantation of paddle type spinal cord stimulation (SCS) electrodes, data are lacking on the frequency, causes, and prevention of these complications.
The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]Spinal cord stimulation (SCS) has been proven effective for multiple chronic pain syndromes. Over the past 40 years of use, the complication rates of SCS have been well defined in the literature; however, the incidence of one of the most devastating complications, spinal cord injury (SCI), remains largely unknown. The goal of the study was to quantify the incidence of SCI in both percutaneous and paddle electrode implantation.
Anticipating and preventing complications in spinal cord stimulator implantation. [2023]Spinal cord stimulation is considered a minor elective procedure. The inherent goal is to provide safe, reliable, effective treatment with mitigation of known potential risk of adverse events.
Spinal direct current stimulation with locomotor training in chronic spinal cord injury. [2021]Transcutaneous spinal direct current stimulation (tsDCS) is a non-invasive method of stimulating spinal circuits that can modulate and induce changes in corticospinal excitability (CE) in incomplete spinal cord injury (SCI). A double-blinded sham controlled study of 2 male patients (A and B) with SCI was carried out. Patient A received sham and cathodal tsDCS, while Patient B received sham and anodal tsDCS. Four baselines were recorded prior to each arm of stimulation. Outcomes were then measured post each arm of stimulation; 10-meter walk test, modified ashworth scale, berg balance scale, manual muscle testing, and spinal cord independence measure-III. Transcranial magnetic stimulation, assessed motor evoked potentials. Cathodal tsDCS increased the scores in few of the outcome measures and decreased others. Anodal stimulation increased scores in all measures. Motor evoked potentials increased in post-cathode and deteriorated in post-anode. In conclusion, tsDCS modulated gait parameters, spasticity, and CE in incomplete SCI.