Non-invasive BCI-controlled Assistive Devices
NCT05183152 · Motor Disorders, Healthy, Spinal Cord Injuries
RecruitingInjuries affecting the central nervous system may disrupt the cortical pathways to muscles causing loss of motor control. Nevertheless, the brain still exhibits sensorimotor rhythms (SMRs) during movement intents or motor imagery (MI), which is the mental rehearsal of the kinesthetics of a movement without actually performing it. Brain-computer interfaces (BCIs) can decode SMRs to control assistive devices and promote functional recovery. Despite rapid advancements in non-invasive BCI systems based on EEG, two persistent challenges remain: First, the instability of SMR patterns due to the non-stationarity of neural signals, which may significantly degrade BCI performance over days and hamper the effectiveness of BCI-based rehabilitation. Second, differentiating MI patterns corresponding to fine hand movements of the same limb is still difficult due to the low spatial resolution of EEG. To address the first challenge, subjects usually learn to elicit reliable SMR and improve BCI control through longitudinal training, so a fundamental question is how to accelerate subject training building upon the SMR neurophysiology. In this study, the investigators hypothesize that conditioning the brain with transcutaneous electrical spinal stimulation, which reportedly induces cortical inhibition, would constrain the neural dynamics and promote focal and strong SMR modulations in subsequent MI-based BCI training sessions - leading to accelerated BCI training. To address the second challenge, the investigators hypothesize that neuromuscular electrical stimulation (NMES) applied contingent to the voluntary activation of the primary motor cortex through MI can help differentiate patterns of activity associated with different hand movements of the same limb by consistently recruiting the separate neural pathways associated with each of the movements within a closed-loop BCI setup. The investigators study the neuroplastic changes associated with training with the two stimulation modalities.
PhaseNA
TypeInterventional
Age18 Years – 80 Years
WhereAustin, Texas, United States
SponsorUniversity of Texas at Austin
▾Tap for detailsClick for full details — eligibility, all locations, contacts Music-4-MS to Improve Cognition in People Living With Multiple Sclerosis: A Feasibility Study
NCT07759115 ·
Multiple Sclerosis, Pathologic Processes, Demyelinating Autoimmune Diseases, CNS
RecruitingMultiple sclerosis (MS) rates in the U.S. have nearly doubled over the past decade, making it a leading cause of nontraumatic functional impairment in young adults and significantly affecting cognitive function in up to 70% of people with MS. While traditional cognitive rehabilitation methods are limited in sensory engagement, music training offers a multisensory approach that enhances neuroplasticity and improves cognitive functions. This study investigates the feasibility of Music-4-MS, a 12-week music-based eHealth intervention, to support cognitive and emotional health in individuals with MS.
PhaseNA
TypeInterventional
Age18 Years – 80 Years
WhereAustin, Texas, United States
SponsorUniversity of Texas at Austin
▾Tap for detailsClick for full details — eligibility, all locations, contacts RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
NCT07002034 · Adjustment Disorder
RecruitingThe purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.
PhasePhase 2
TypeInterventional
Age18 Years – 80 Years
WhereBirmingham, Alabama, United States + 31 more
SponsorReunion Neuroscience Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Multiple Sclerosis Implementation Network (Registry)
RecruitingThe Multiple Sclerosis Implementation Network (MSIN) is a collaboration between the Multiple Sclerosis Association of America (MSAA), The University of Texas Health Science Center at Houston (UTHealth Houston), Dell Medical School at The University of Texas at Austin, and Novartis Pharmaceuticals Corporation. The goal of MSIN is to improve Multiple Sclerosis (MS) care, patient health, and quality of life through the development and support of implementation research and clinical practice collaboration. MSIN brings together healthcare teams, people with MS, and research leaders in MS and implementation science (IS) to learn, share, test, implement, and disseminate innovations that improve MS care, patient health, and quality of life. This ClinicalTrials.gov record pertains to the MSIN Patient Registry, which is a comprehensive database that integrates participants' electronic health records from various providers.
Phase—
TypeObservational
Age18 Years
WhereCherry Hill, New Jersey, United States + 2 more
SponsorThe University of Texas Health Science Center, Houston
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of COYA 302 for the Treatment of ALS
RecruitingThe ALSTARS trial will be conducted across 20-25 sites in the US and Canada, and will evaluate the safety and efficacy of an investigational treatment called COYA 302 for adults with Amyotrophic Lateral Sclerosis (ALS). COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. It is comprised of low dose interleukin-2 (LD IL-2) and DRL\_AB (a biosimilar candidate for abatacept). Participants will be randomly assigned to receive one of 2 regimens of COYA 302 or placebo (an inactive substance) in a 1:1:1 ratio for 24 weeks in the double-blind (DB) period. Those who complete this part of the study will be eligible to receive one of the two regimens of COYA 302 for an additional 24 weeks in a blinded active extension phase (EXT). The study will assess changes in disease progression using established ALS clinical outcome measures, including the ALS Functional Rating Scale-Revised (ALSFRS-R), neurofilament (NfL), maximal inspiratory pressure (MIP), slow vital capacity (SVC), and neurological assessments. Additional objectives include evaluation of biomarkers and safety through routine clinical assessments and adverse event monitoring.
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years – 80 Years
WherePhoenix, Arizona, United States + 24 more
SponsorCoya Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study
RecruitingThe MS pilot study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult patients diagnosed with relapsing-remitting multiple sclerosis (RRMS). The SetPoint System is intended for adjunctive use with standard of care therapy for RRMS. The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 60 participants at up to 10 sites. All eligible participants will undergo the implant procedure. Two-thirds of the participants will receive active stimulation (treatment) and the one-third will receive non-active stimulation (control). Following treatment evaluations at Week 48, there will be a one-way crossover of control subjects to active stimulation and a 48-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.
PhaseNA
TypeInterventional
Age22 Years – 60 Years
WhereIrvine, California, United States + 8 more
SponsorSetPoint Medical Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
RecruitingThe purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
PhasePhase 2
TypeInterventional
Age18 Years – 70 Years
WhereBirmingham, Alabama, United States + 54 more
SponsorCelgene
▾Tap for detailsClick for full details — eligibility, all locations, contacts AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy
NCT06063850 · Mesial Temporal Lobe Epilepsy
RecruitingThe main goals of this clinical study are to learn if AMT-260 is safe and tolerable and works to reduce the frequency of seizures in adults with unilateral mesial temporal lobe epilepsy (MTLE).
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years – 75 Years
WhereBirmingham, Alabama, United States + 17 more
SponsorUniQure Biopharma B.V.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
RecruitingThe purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).
PhasePhase 3
TypeInterventional
Age40 Years – 70 Years
WhereScottsdale, Arizona, United States + 128 more
SponsorNovartis Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
RecruitingThe purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting
Phase—
TypeObservational
Age18 Years
WhereBirmingham, Alabama, United States + 108 more
SponsorTG Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts