Deep Brain Stimulation for Thalamic Pain Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Andre Machado
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of Participants With 50% Improvement in Pain Related Disability (as Assessed by the Pain Disability Index)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
This is a pilot clinical study of the therapeutic benefits of ventral capsular/ventral striatal deep brain stimulation (DBS) as a treatment for 10 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.
Investigators
Andre Machado
Staff Physician
The Cleveland Clinic
Eligibility Criteria
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
Exclusion Criteria
- •Not capable of understanding or providing informed consent.
- •Aphasia severe enough to limit the consent process or communication between the investigators and the patient. Patients with mild or recovering aphasia may be considered candidates at the discretion of the PI.
- •Coagulopathy. Patients will be excluded unless assessed and cleared by hematology
- •Inability to stop Coumadin or platelet anti-aggregation therapy for surgery and after surgery. Patients taking these medications will need to discuss the need/risk of continuing these medications with their physicians and the PI or study personnel may contact the treating physician(s) as well to discuss the risks of anticoagulation / antiaggregation therapy discontinuation.
- •Uncontrolled hypertension.
- •Malignancy with \< 5 years life expectancy.
- •Major medical co-morbidities: end stage renal failure, heart failure, severe congestive heart disease, severe respiratory problems, liver failure or other significant medical co morbidities.
- •Major neurological disorder other than the one that led to the TPS.
- •MRI (done within one year of the first visit) with abnormalities other than those associated with the neurological disorder causing TPS.
- •Age \< 21 years.
Outcomes
Primary Outcomes
Number of Participants With 50% Improvement in Pain Related Disability (as Assessed by the Pain Disability Index)
Time Frame: Blinded stimulation phase (3 Months)
Pain Disability Index (PDI) directly measures disability related to the main components of daily life function and has been validated for thalamic pain syndrome. Range is 0 (no disability) to 10 (worst disability). The components are Family/Home Responsibilities, Recreation, Social Activity, Sexual Behavior, Life-support Activity, Occupation, \& Self-care. This is an average score of the 3 month period for each Active and Sham phase.
Secondary Outcomes
- Number of Participants Who Would Undergo the Procedure Again.(End of Open Label Phase (24 months))
- Number of Patient Who Had >50% Reduction in VAS.(Baseline and 24 months)
- Number of Participants Who Had 50% Improvement in PDI(24 months post randomization follow up)