The goal of this study is to verify whether the use of deep brain stimulation can improve motor function of the hand and arm and speech abilities for people following a stroke. Participants will undergo a surgical procedure to implant deep brain stimulation electrode leads. The electrodes will be connected to external stimulators and a series of experiments will be performed to identify the types of movements that the hand and arm can make and how speech abilities are affected by the stimulation. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neuro-rehabilitation programs to restore speech and upper limb motor functions in people with subcortical strokes, thereby increasing independence and quality of life.
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 outside this age range may be at an increased medical risk and have an increased risk of fatigue during testing).
English speaker.
Participant must score ≤ 80% in at least 4 categories of the perceptual speech assessment (speech intelligibility, listener effort, speech naturalness, articulatory precision, speech rate, overall voice quality, and/or overall speech severity). OR ≤ 80% in at least 3 categories of the perceptual speech assessment AND ≤ 27 on the Communicative Participation Item Bank.
Patients who refuse participation in the study.
Patients with gross anatomical variances in MR imaging or cerebral vascular accidents involving thalamic and cerebellar areas.
Patients with no clinical condition to undergo DBS implantation or highly dependent on anticoagulation therapy.
Patients who cannot undergo pre-operative MRIs or could not complete the pre-operative assessments.
Single group
Deep Brain Stimulation (DBS) of the Motor Thalamus
DeviceAll participants enrolled in this group will undergo a surgical procedure to implant deep brain stimulation electrode leads. The electrodes will be connected to external stimulators and a series of experiments will be performed to identify the types of movements that the hand and arm can make and how speech abilities are affected by the stimulation. The implant will be removed after less than 30 days.
Adverse Events
The investigators will quantify the safety of DBS to treat post-stroke speech and upper-limb motor deficits. For this, the investigators will record all adverse events for the entire study duration. The study is considered successful if no serious adverse events related to the use of deep brain stimulation are reported.
Discomfort and Pain
The investigators will assess the relative level of discomfort and/or pain that is associated with the delivery of electrical stimulation to the motor thalamus. After each stimulation train patients will be asked to report a level of perceived discomfort using a 10 value subjective scale. Low values will be assigned to low discomfort and high values to high discomfort. The study is considered successful if 70% of recruited subjects do not report discomfort or pain at stimulation amplitudes that are required to obtain motor responses in the face and upper-limb muscles.
Dysphagia
The investigators will use the modified barium swallow study (MBSS) to assess oropharyngeal swallow functions. This is a performance evaluation scale, that consist of 17 items with varying scales. The total score ranges from 0 to 55, where a higher score means a better outcome. Based on the preliminary data, the investigators will consider an increase of 1 point in at least 50% of the items of the Modified Barium Swallow Impairment Profile as a minimally acceptable improvement in swallow functions.
Hand dexterity
The investigators will use the Box and Blocks Test to measure hand dexterity ability. Based on the preliminary data, the investigators will consider a percentage change of 18% as a minimally acceptable improvement in hand dexterity.
Muscle weakness
The investigators will measure muscle strength and range of motion produced by the subject during isometric facial movements (e.g. smile, tongue out, puckered lips, and open-close mouth). Based on the preliminary data, the investigators will consider an increase of 50% in ROM as a minimally acceptable improvement in muscle strength.
Dexterity of Articulation AMRs
The investigators will measure dexterity of articulation by alternating motion rates (AMRs) of the repetitive plosive sound (pah, tah, and kah). The investigators will consider an improvement of 10% in the rate to be minimally acceptable.
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Jorge Gonzalez-Martinez
Lead sponsor
University of Pittsburgh
Sponsor institution
