Track topics on Twitter Track topics that are important to you
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
Deep brain stimulation (DBS) of the sensory thalamus has been proposed for 40 years to treat medically refractory neuropathic pain, but its efficacy remains partial and unpredictable. Rece...
The purpose of this study is to determine whether deep brain stimulation is effective at reducing tic frequency and severity in adults with Tourette syndrome.
This study evaluates invasive deep brain stimulation (DBS) in the treatment of chronic neuropathic pain. Half of the participants will be assigned to a group with recording / stimulation t...
Dystonia is increasingly being considered as a multi-nodal network disorder involving both basal ganglia and cerebellar dysfunction. The aim of this study is to determine if "Multi-Target"...
Laryngeal Dystonia (LD), also commonly referred to as spasmodic dysphonia, is a neurological voice disorder characterized by involuntary dystonic contractions of the laryngeal muscles. Cur...
transcranial Direct Current Stimulation (tDCS) is a non-invasive method of brain stimulation suggested as a therapeutic tool for pain, and is related to reversal of maladaptive plasticity associated w...
Fibromyalgia and irritable bowel syndrome are common disorders which often coexist in women with chronic pelvic pain. Like pelvic pain, these disorders describe symptoms without pathologic findings. W...
Voice tremor (VT) is the involuntary and rhythmical phonatory instability of the voice. Recent findings suggest that unilateral deep brain stimulation of the ventral intermediate nucleus (Vim-DBS) can...
Thalamic pain is a severe pain that is often unresponsive to medical therapy. Repetitive transcranial magnetic stimulation (rTMS) entirely non-invasively modulates neuronal plasticity to produce thera...
Pain significantly decreases the quality of life. The treatment of back pain relies heavily on comprehensive rehabilitation. This study compared the effectiveness of deep electromagnetic stimulation a...
A chronic PELVIC PAIN characterized by pain deep in the buttock that may radiate to posterior aspects of the leg. It is caused by the piriformis muscle compressing or irritating the SCIATIC NERVE due to trauma, hypertrophy, inflammation or anatomic variations.
A syndrome characterized by retropatellar or peripatellar PAIN resulting from physical and biochemical changes in the patellofemoral joint. The pain is most prominent when ascending or descending stairs, squatting, or sitting with flexed knees. There is a lack of consensus on the etiology and treatment. The syndrome is often confused with (or accompanied by) CHONDROMALACIA PATELLAE, the latter describing a pathological condition of the CARTILAGE and not a syndrome.
Amount of stimulation required before the sensation of pain is experienced.
A type of pain that is perceived in an area away from the site where the pain arises, such as facial pain caused by lesion of the VAGUS NERVE, or throat problem generating referred pain in the ear.
Pain in the facial region including orofacial pain and craniofacial pain. Associated conditions include local inflammatory and neoplastic disorders and neuralgic syndromes involving the trigeminal, facial, and glossopharyngeal nerves. Conditions which feature recurrent or persistent facial pain as the primary manifestation of disease are referred to as FACIAL PAIN SYNDROMES.
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...