grant

Transspinal Magnetic Stimulation for the Treatment of Neuropathic Pain

Organization MASSACHUSETTS GENERAL HOSPITALLocation BOSTON, UNITED STATESPosted 18 Sept 2024Deadline 31 Aug 2027
NIHUS FederalResearch GrantFY2024AbscissionAddressAdvanced DevelopmentAnalgesia TestsAnatomic SitesAnatomic structuresAnatomyAnimal ModelAnimal Models and Related StudiesAnimal TestingAnimalsAreaArizonaBackBack AcheBack PainBackacheBehaviorCNS Nervous SystemCentral Nervous SystemCephalicChestClinical TrialsCommon Rat StrainsCranialDevice FailuresDevicesDorsalDorsal Root GangliaDorsumDrugsEffectivenessEligibilityEligibility DeterminationEnsureEquipment MalfunctionEvaluationExcisionExtirpationFamily suidaeFibular NerveFocused UltrasoundFocused Ultrasound AblationFocused Ultrasound TherapyFocused Ultrasound TreatmentFrequenciesFunctional MRIFunctional Magnetic Resonance ImagingGelGeneral HospitalsHeatingHigh Power Focused UltrasoundHigh-intensity focused ultrasoundHumanImplantImplantation procedureInfectionLeadLegLeg PainMR ImagingMR TomographyMRIMRIsMagnetic Resonance ImagingMagnetismMassachusettsMedical Imaging, Magnetic Resonance / Nuclear Magnetic ResonanceMedicationMedulla SpinalisMethodsModalityModern ManMuscleMuscle TissueNMR ImagingNMR TomographyNerveNeural PathwaysNeuraxisNeurologicNeurologicalNeuropathyNeurostimulation procedures of spinal cord tissueNeurosurgeonNociception TestsNuclear Magnetic Resonance ImagingOperative ProceduresOperative Surgical ProceduresOutcomePainPain AssessmentPain ControlPain MeasurementPain TherapyPain in lower limbPain managementPain measurePainfulParesthesiaPathway interactionsPatientsPb elementPerformancePeripheralPharmaceutical PreparationsPharmacological TreatmentPhysiologic pulsePigsPilot ProjectsPositionPositioning AttributeProceduresProtocol ScreeningPulseRadial NerveRatRats MammalsRattusRemovalResearchResistanceRiskRodentRodent ModelRodentiaRodents MammalsSafetySciatic NeuralgiaSciaticaSecureSpinalSpinal CordSpinal Cord StimulationSpinal GangliaStructureStructure of radial nerveSuidaeSurgicalSurgical InterventionsSurgical ProcedureSurgical RemovalSwineSystemTechniquesTechnologyTestingTherapeuticThoraceThoracicThoracic Portion of Spinal CordThoracic Spinal CordThoracic spinal cord structureThoraxTimeTransmissionUniversitiesValidationWorkZeugmatographyaddictionaddictive disorderanimal painbiocompatibilitybiomaterial compatibilitychronic neuropathic painchronic painclinical applicabilityclinical applicationclinical trial readinessdesigndesigningdiagnostic tooldorsal columndorsal root gangliondrug/agentexperienceexperimentexperimental researchexperimental studyexperimentsfMRIheavy metal Pbheavy metal leadhuman modelimplant placementimplant procedureimplantationinnovateinnovationinnovativemagneticmagnetic fieldmanufacturemedical attentionmeetingmeetingsmigrationminiaturizeminiaturizedmodel of animalmodel of humanmuscularnerve injuryneural controlneural injuryneural regulationneural stimulationneuro-surgeonneuromodulationneuromodulatoryneuropathicneuropathic painneuroregulationnovelopiate consumptionopiate drug useopiate intakeopiate useopioid consumptionopioid drug useopioid intakeopioid usepain assaypain modelpain perceptionpain reductionpain reliefpain treatmentpainful neuropathypathwayperoneal nervepig modelpiglet modelpilot studypilot trialporcineporcine modelposterior columnpre-clinicalpre-clinical studypreclinicalpreclinical studyreduce painrelieve painresectionresistantresponseside effectsimulationsuccesssuidsurgeryswine modeltime usetooltransmission processvalidations
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Full Description

ABSTRACT.
Chronic pain ranks among the top reasons for seeking medical attention. Spinal Cord Stimulation (SCS) has

been a traditional approach for managing chronic neuropathic pain in the back and legs. This method, however,

involves an invasive procedure that requires the patient to live with an implant. In contrast, Low-Intensity Focused

Ultrasound (LIFU) presents a non-invasive alternative explored in clinical trials for modifying central nervous

system activity, promising quicker neuromodulation for pain relief. Our research shows that a brief, three-minute

LIFU treatment targeting the dorsal root ganglion (DRG) can suppress pain responses in small and large animal

models for extended periods. Yet, targeting other crucial spinal areas for pain management, like the dorsal

columns, remains a challenge due to anatomical constraints.

Building on the development of an advanced miniaturized Transcranial Stimulation (TMS) system, our project

aims to create a groundbreaking High Frequency (HF) Trans-Spinal Magnetic Stimulation (TSMS) tool. This new

system draws upon previous successes in dorsal column stimulation research and numerical simulations, setting

the stage for the first non-invasive dorsal spinal cord stimulation to address back pain. Utilizing a novel 10kHz

magnetic pulse, the HF-TSMS system mirrors the frequency used in invasive SCS treatments, which have been

effective in managing sciatica and significantly reducing opioid use among patients.

We aim to refine HF-TSMS to target neural pathways involved in neuropathic back and leg pain. To achieve

this, we plan to conduct experimental studies using rodent models at Massachusetts General Hospital, assessing

pain responses via fMRI. Further efficacy and safety evaluations will be conducted in larger animal models at

the University of Arizona. Following these studies, we aim to secure an Investigational Device Exemption (IDE)

and initiate a preclinical pilot trial in humans suffering from neuropathic pain. The introduction of HF-TSMS as a

non-invasive, drug-free treatment option could significantly impact the management of chronic neuropathic pain,

offering new hope for patients with sciatica.

Grant Number: 1R18EB036591-01
NIH Institute/Center: NIH

Principal Investigator: GIORGIO BONMASSAR

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