Safety Study of Deep Brain Stimulation to Manage Thalamic Pain Syndrome
CompletedNot applicableNCT01072656
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Deep Brain Stimulation for Thalamic Pain Syndrome
- Conditions
- Interventions
- Device: Deep Brain Stimulation for Thalamic Pain Syndrome
- Sponsor
- Andre Machado
- Collaborators
- National Institutes of Health (NIH)
- Organization
- The Cleveland Clinic
- Start date
- 2010-05
- Primary completion
- 2014-08
- Sex
- All
- Age range
- from 21 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Clinical diagnosis of thalamic pain syndrome * with allodynia or dysesthesia * with pinprick anesthesia or hypoesthesia on the affected hemibody (anesthesia dolorosa). * Six months or more of medically refractory severe pain (see below). * Pain disability reported by the pain index \>30 points at the time of enrollment. * Average daily pain for the past 30 days reported as \>5 on a 0-10 scale * Failure to respond adequately to at least one antidepressant, one anti-seizure medication and one oral narcotic. * MRI done within one year of the first visit showing a lesion that involves the posterior thalamic region or a lesion in the dorsal or ventral vicinity of the thalamus (i.e. semi oval white matter or brain stem). The lesion will be contralateral to the hemibody affected by chronic pain or will involve cortical-subcortical areas in topography consistent with sensory thalamocortical connections. This will include patients with infarcts in the territory of the middle cerebral artery. A more recent MRI may be required if the patient's condition changed within the previous year. * Capable of understanding and providing informed consent * Age ≥ 21 years * Women of childbearing age must be on regular use of an accepted contraceptive method(s). * Previous surgical procedures: Patients with severe and refractory thalamic pain syndrome may have undergone other interventional or surgical procedures, as an attempt to alleviate the thalamic pain syndrome. Surgical procedure may include blocks, spinal cord stimulation, thalamic DBS, posterior limb of the internal capsule DBS or periaqueductal gray / periventricular gray DBS, cortical stimulation, peripheral ablative procedures or cerebral ablative procedures. In this study, patients with previously implanted cortical stimulation systems, or spinal and peripheral nervous system stimulation systems may be included. However, patients with previous motor cortex stimulation must have had the cortical stimulation system before being considered a candidate for this protocol. Removal of the cortical stimulation system will not be covered under this protocol. Patients with spinal or peripheral neuromodulation system may be included in the research provided that the implanted systems are compatible with the all research protocols (including fMRI) to be performed during the research. Patients with pervious DBS implants will not be considered candidates. Exclusion Criteria: * Not capable of understanding or …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01072656