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The purpose of this study is to determine the safety and efficacy of Deep Brian Stimulation (DBS) of the ventral capsular/ventral striatal as a treatment for patients with Thalamic Pain Syndrome (TPS). The central hypothesis to be tested in this investigation is that VC/VS stimulation will modulate the affective component of TPS and, consequently, improve pain related disability.
This is a pilot clinical study of the therapeutic benefits of ventral capsular/ventral striatal deep brain stimulation (DBS) as a treatment for 34 patients with medically refractory thalamic pain syndrome. Patients to be enrolled under this protocol will have experienced severe pain for more than six months and will be considered medically refractory. Study subjects may have undergone and failed other surgical procedures or interventional procedures. Study subjects will have chronic, medically refractory pain of disabling severity, refractory to treatment attempts with conventional medications. Patients that are enrolled in the study will have bilateral DBS surgery, with implantation of one Medtronic 3391 DBS lead on either side of the brain. These leads will then be connected at first to a single Medtronic PC pulse generator to be implanted in the infraclavicular region on one side. Once the PC pulse generator is depleted, and the patient has completed the blinded phase of the study, the PC pulse generator will be replaced for an RC pulse generator. The RC pulse generator has a battery life of 9 years and is a good option for the open label phase and for continued stimulation after the study is completed. However, the RC is not ideal for the blinded phase because patients may be able to tell if they are receiving active or sham stimulation. For this reason, patients enrolled in this study will receive, initially, the implant with the PC generator. Patients will have at least 6 months of stable chronic pain associated with TPS.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Deep Brain Stimulation for Thalamic Pain Syndrome
Cleveland Clinic Foundation
Not yet recruiting
The Cleveland Clinic
Published on BioPortfolio: 2014-08-27T03:15:44-0400
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