Phase
Condition
Neurologic Disorders
Stroke
Cerebral Ischemia
Treatment
Deep Brain Stimulation (DBS) of the Motor Thalamus
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have suffered a single, ischemic, or hemorrhagic stroke more than 6 months before the time of enrollment with dysarthria as a result.
Participants must be between the ages of 18 and 75 years old. (Participants outsidethis age range may be at an increased medical risk and have an increased risk offatigue during testing).
English speaker.
Participant must score ≤ 80% in at least 4 categories of the perceptual speechassessment (speech intelligibility, listener effort, speech naturalness,articulatory precision, speech rate, overall voice quality, and/or overall speechseverity). OR ≤ 80% in at least 3 categories of the perceptual speech assessment AND ≤ 27 on the Communicative Participation Item Bank.
Exclusion
Exclusion Criteria:
Patients who refuse participation in the study.
Patients with gross anatomical variances in MR imaging or cerebral vascularaccidents involving thalamic and cerebellar areas.
Patients with no clinical condition to undergo DBS implantation or highly dependenton anticoagulation therapy.
Patients who cannot undergo pre-operative MRIs or could not complete thepre-operative assessments.
Participants must not have any serious disease or disorder (ex. neurologicalcondition other than stroke, cancer, severe cardiac or respiratory disease, renalfailure, etc.) or cognitive impairments that could affect their ability toparticipate in this study.
Female participants of child-bearing age must not be pregnant, planning to becomepregnant for the next 9 months, or breast feeding.
Participants must not be receiving anticoagulants.
Severe claustrophobia.
Participants must not be on anti-spasticity or anti-epileptic medications for theduration of the study.
Participants who have been deemed inappropriate for participation based upon resultsfrom the Brief Symptoms Inventory (BSI-18) and discussions with the PrincipalInvestigator and a study physician
Evaluation to sign consent form score <12.
MRI contraindications (excluding subjects who are pregnant, who have metal in anyportion of their body, have medical complications, cardiac pacemaker, cochlearimplant, aneurysm clip, certain IUDs, or known problems of claustrophobia).
Medications with common cognitive side-effects.
Bleeding disorders or platelet dysfunction (e.g., from regular aspirin usage).
Patients must not have any lesions in the lower motoneuron causing flacciddysarthria.
Study Design
Study Description
Connect with a study center
University of Pittsburgh
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
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