Clinical Trials Logo

Spinal Cord Stimulation clinical trials

View clinical trials related to Spinal Cord Stimulation.

Filter by:

NCT ID: NCT06000592 Recruiting - Clinical trials for Spinal Cord Injuries

Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

This site-specific project will focus on a novel non-pharmacologic approach to stabilizing BP during AIR after acute traumatic SCI. Current forms of pharmacologic and non-pharmacologic treatments for hypotension and OH remain inadequate in the SCI population. A critical need exists for the identification of safe, practical and effective treatment options that stabilize BP after traumatic SCI. Transcutaneous Spinal Cord Stimulation (TSCS) has several advantages: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. TSCS represents an alternate approach to epidural SCS, with far greater potential to reach large numbers of individuals, thus providing for a greater likelihood of clinical implementation with far fewer risks. We are asking the key question: what if applying SCS earlier after injury could prevent the development of BP instability? To facilitate adoption of TSCS for widespread clinical use, we have designed a spatial-temporal mapping and parameter configuration approach that will result in a key deliverable for SCI care: a standard, easy to follow algorithm that will maximize individual benefits of spinal neuromodulation, while minimizing the burden on healthcare professionals. This project will provide the foundational evidence to support the feasible and safe application of TSCS for widespread clinical utility in the newly injured population, thereby overcoming barriers to engagement in prescribed AIR regimens that are imposed by ANS dysfunction.

NCT ID: NCT05861609 Recruiting - Clinical trials for Spinal Cord Stimulation

Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.

PIANISSIMO
Start date: September 29, 2023
Phase: N/A
Study type: Interventional

The primary objective of the study is to examine whether there is a difference in disability after 12 months of Spinal Cord Stimulation (SCS) in patients with Persistent Spinal Pain Syndrome Type 2 (PSPS T2) after receiving a standardized pain medication tapering protocol before SCS implantation, a personalized pain medication tapering protocol before SCS implantation, or no tapering protocol before SCS implantation. The secondary objective of the study is to examine whether there is a difference after 12 months of SCS in PSPS T2 patients after receiving a standardized pain medication tapering protocol before SCS implantation, a personalized pain medication tapering protocol before SCS implantation, or no tapering protocol before SCS implantation on pain intensity, health-related quality of life, participation, domains affected by substance use, anxiety and depression, medication use, psychological constructs, sleep, central sensitization, and healthcare expenditure.

NCT ID: NCT05794776 Recruiting - Clinical trials for Spinal Cord Stimulation

Effect of Spinal Cord Stimulation (SCS) on Insulin Secretion in Humans

Start date: March 16, 2023
Phase: N/A
Study type: Interventional

This trial investigates the effect of BurstDR and tonic spinal cord stimulation (SCS) on glucose metabolism and heart rate variability in patients with neuropathic pain.

NCT ID: NCT05712980 Not yet recruiting - Clinical trials for Failed Back Surgery Syndrome

Transcriptomic Profile of Patients Treated With Different Modalities of Spinal Cord Stimulation

SCS-OMICS
Start date: February 2023
Phase:
Study type: Observational

Failed Back Surgery Syndrome (FBSS) is a relatively common condition that can cause a severe disability in patients. Spinal cord stimulation (SCS) is used in those patients refractory to conventional therapies.In this project the investigators aim to identify new functional molecular basis, defined with transcriptomic profiling, differentially represented in the serum of patients suffering chronic pain caused by FBSS. The investigators will try to Identify "omics" markers for diagnosing and monitoring the process of development and maintenance of pain as well as the evaluation of these as evolutionary disease markers or predictors of the response to SCS therapy. To carry out the project, 40 patients diagnosed with refractory FBSS and treated with an SCS system for pain management will be included. Blood samples will be obtained to analyze the transcription profiling in plasma of patients responding to different modalities of SCS therapy.

NCT ID: NCT05704751 Not yet recruiting - Clinical trials for Back Pain Lower Back Chronic

EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients

ECAP
Start date: November 1, 2023
Phase:
Study type: Observational

This study is designed to evaluate the feasibility of using intra-operative ECAP and Late-Response (LR) recordings for confirmation of activating the neuronal target of the dorsal column in a single-stage SCS lead placement procedure. The collected ECAP and LR data will be analysed post-hoc to further evaluate its utility for determining the laterality of lead placement with respect to the physiologic midline of the dorsal column.

NCT ID: NCT05466110 Recruiting - Low Back Pain Clinical Trials

Spinal Cord Stimulation Versus Instrumentation for FBSS

PROMISE
Start date: March 20, 2023
Phase: N/A
Study type: Interventional

Low back pain affects people of all ages and has become the leading cause of living with disability worldwide. Patients, suffering from persistent pain after spinal surgery in the absence of any clear spinal pathology are defined of having a "failed back surgery syndrome (FBSS)" and treatment of FBSS remains a great controversy in the spinal community. Apart from conservative treatment, spinal fusion remains as therapeutic option. Furthermore, minimal invasive Neuromodulation techniques might be a promising alternative. Aim of this randomized interventional multi center study is to compare treatment success in FBSS patients with either spinal cord stimulation (SCS) or fusion surgery, 12 months after intervention according to the Oswestry Disability Index (ODI) and other scales and scores. Radiological and health economic outcome also will be analysed for thorough comparison of techniques. Additionally, the safety of the interventions needs to be compared.

NCT ID: NCT05283863 Completed - Clinical trials for Spinal Cord Stimulation

Direct Comparison of Spinal Cord Stimulator Parameter Settings

Start date: June 2015
Phase: N/A
Study type: Interventional

(Primary) 1. To compare the clinical effects and side effects of two different stimulation strategies that do not produce any sensory percept (1000 Hz and placebo) on clinical benefit for electrodes implanted for chronic pain as measured by the Visual Analog Pain Scale for back and leg pain, the Brief Pain Inventory, the SF-36, and the Pain Vigilance and Awareness Questionnaire. (Secondary) 2. To compare the clinical effects of the subthreshold (paresthesia-free) stimulation patterns with conventional (paresthesia-producing) stimulation patterns to evaluate the necessity of paresthesias and current amplitudes on clinical benefit for pain. 3. To identify the ability of subthreshold high-frequency to improve axial pain or the affective component of pain.

NCT ID: NCT05269212 Recruiting - Clinical trials for Failed Back Surgery Syndrome

Return to Work for Persistent Spinal Pain Syndrome Type II Patients

OPERA
Start date: May 10, 2022
Phase: N/A
Study type: Interventional

A multicenter randomized controlled trial will be conducted to evaluate whether the ability to work in Persistent Spinal Pain Syndrome Type II (PSPS-T2) patients after SCS implantation is different after a personalized biopsychosocial rehabilitation program specifically targeting return to work (RTW) compared with usual care.

NCT ID: NCT05178056 Recruiting - Clinical trials for Spinal Cord Injuries

Spinal Cord Stimulation and Respiration After Injury

Start date: December 31, 2021
Phase: N/A
Study type: Interventional

Respiratory motor control deficit is the leading cause of morbidity and mortality in patients with spinal cord injury. The long-term goal of this NIH-funded study is to develop a rehabilitation strategy for respiration in patients with spinal cord injury as a standard of care. Respiratory function in patients with chronic spinal cord injury can be improved by using inspiratory-expiratory pressure threshold respiratory training protocol. However, the effectiveness of this intervention is limited by the levels of functional capacity preserved below the neurological level of injury. Preliminary data obtained for this study demonstrate that electrical spinal cord stimulation applied epidurally at the lumbar level in combination with respiratory training can activate and re-organize spinal motor networks for respiration. This study is designed to investigate respiratory motor control-related responses to epidural spinal cord stimulation alone and in combination with respiratory training. By characterization of respiratory muscle activation patterns using surface electromyography in association with pulmonary functional and respiration-related cardiovascular measures, the investigators expect to determine the specific stimulation parameters needed to increase spinal excitability below level of injury to enhance responses to the input from supraspinal centers that remain after injury and to promote the neural plasticity driven by the respiratory training. This hypothesis will be tested by pursuing two Specific Aims: 1) Evaluate the acute effects of epidural spinal cord stimulation on respiratory functional and motor control properties; and 2) Evaluate the effectiveness of epidural spinal cord stimulation combined with respiratory training.

NCT ID: NCT04960592 Recruiting - Chronic Pain Clinical Trials

Epigenetic Mechanisms and Symptom Clusters Associated With Resolution of Pain Following Spinal Cord Stimulation

Start date: February 15, 2021
Phase:
Study type: Observational

Spinal cord stimulation (SCS) is indicated for selected patients with chronic pain who have not responded to conventional medical management. Forty (40) patients indicated for SCS placement and presenting to the University of Arkansas for Medical Sciences (UAMS) Interventional Pain Management Clinic in Little Rock, Arkansas will be recruited for this study. Prior to temporary stimulator placement, patients will complete symptom-related questionnaires and provide a blood sample. Demographic and clinical characteristics will be obtained through medical record review. Patients will complete the same questionnaires and provide a blood sample at each of the routine clinical care follow-up visits.