StrokeNCT06303869
Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke
A study testing Deep Brain Stimulation (DBS) of the Motor Thalamus in people with Stroke and Brain Disease, run by Jorge Gonzalez-Martinez at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Brain Disease, Central Nervous System Diseases
- What is being tested?
- Deep Brain Stimulation (DBS) of the Motor Thalamus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Participants must not have any serious disease or disorder (ex. neurological condition other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) or cognitive impairments that could affect their ability to participate in this study.
- Female participants of child-bearing age must not be pregnant, planning to become pregnant for the next 9 months, or breast feeding.
Show all 15Show fewer
- Participants must not be receiving anticoagulants.
- Severe claustrophobia.
- Participants must not be on anti-spasticity or anti-epileptic medications for the duration of the study.
- Participants who have been deemed inappropriate for participation based upon results from the Brief Symptoms Inventory (BSI-18) and discussions with the Principal Investigator and a study physician
- Evaluation to sign consent form score \<12.
- MRI contraindications (excluding subjects who are pregnant, who have metal in any portion of their body, have medical complications, cardiac pacemaker, cochlear implant, 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 flaccid dysarthria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Cierra Clark, MS, 240-441-4216, cic27@pitt.edu
About this study
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.
Read the detailed description
The study is designed to assess the assistive effects of DBS (i.e., immediate effects when the stimulation is turned ON) and obtain preliminary evidence for therapeutic effects (i.e., long-lasting effects with stimulation OFF). Researchers will 1) quantify the ability to recruit face muscles with electrical stimulation of the motor thalamus in patients with subcortical stroke, 2) quantify the ability to recruit arm and hand muscles with electrical stimulation of the motor thalamus in patients with subcortical stroke, and 3) verify if the delivery of DBS has effects on the central nervous system with clinical measures.
- Conditions
- Stroke, Brain Disease, Central Nervous System Diseases, Nervous System Diseases, Cardiovascular Diseases
- Being tested
- Deep Brain Stimulation (DBS) of the Motor Thalamus
- Medical subject headings
- Stroke, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation (DBS) of the Motor ThalamusDevice
All 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.
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation of the Motor Thalamus | Experimental | Individuals who have speech and motor deficits due to a stroke. Receives: Device: Deep Brain Stimulation (DBS) of the Motor Thalamus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 29 days
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.
Measured: Baseline, 2 weeks, 4 weeks, 6 months.
Secondary outcomes (8)
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.
Measured: 29 days
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.
Measured: 29 days.
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.
Measured: 29 days
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.
Measured: 29 days
Dexterity of Articulation SMRs
The investigators will measure dexterity of articulation by sequential motion rates (SMRs) of the repetitive plosive sound (pah, tah, and kah). The investigators will consider an improvement of 10% in the rate to be minimally acceptable.
Measured: 29 days
Intelligibility of Speech
The investigators will use the Assessment of Intelligibility of Dysarthric Speech (AIDS) to assess the quality of communication and intelligibility of speech at both word- and sentence-level. The investigators will consider an improvement of 5% correctly transcribed to be minimally acceptable.
Measured: 29 days
Spasticity
Spastic dysarthria is characterized by a higher fundamental frequency (F0) of phoneme utterances than what is seen in normal speech. Thus, the investigators will quantify the degree of spasticity by calculating the F0 across a series of phonemes. The investigators will consider a reduction in F0 of 20% to be minimally acceptable.
Measured: 29 days
Range of Motion (ROM)
The investigators will use the 2nd Edition Frenchay Dysarthria Assessment (FDA-2) to measure patterns of oral motor functions, with a particular focus on the following subsections: Respiration, Lips, Palate, Laryngeal, and Tongue. Each subsection is rated on a scale from "a" to "e", where "a" means normal for age, and "e" means unable to undertake task/movement/sound. So a score closer to "a" means a better outcome. The investigators will consider an improvement in severity level (e.g., from considerable to moderate severity, or a score of D to C) to be minimally acceptable.
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start20 Jun 2025
- Primary completionNov 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized, open-label, descriptive, experimental.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jorge Gonzalez-Martinez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jorge Gonzalez-Martinez, University of Pittsburgh
- Investigators
- Jorge Gonzalez-Martinez, MD/PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303869
- Sponsor's protocol ID
- STUDY22070043
- Status last verified
- May 2026
- First submitted
- 4 Mar 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data may be shared with other researchers for the purpose of data analysis and collaboration.
Publications
Ho, J. et al. TARGETED DEEP BRAIN STIMULATION OF THE MOTOR THALAMUS FACILITATES VOLUNTARY MOTOR CONTROL AFTER CORTICO-SPINAL LESIONS. medRxiv 2023-03 (2023).
Lozano AM, Lipsman N, Bergman H, Brown P, Chabardes S, Chang JW, Matthews K, McIntyre CC, Schlaepfer TE, Schulder M, Temel Y, Volkmann J, Krauss JK. Deep brain stimulation: current challenges and future directions. Nat Rev Neurol. 2019 Mar;15(3):148-160. doi: 10.1038/s41582-018-0128-2.
PubMed 30683913Plow EB, Machado A. Invasive neurostimulation in stroke rehabilitation. Neurotherapeutics. 2014 Jul;11(3):572-82. doi: 10.1007/s13311-013-0245-y.
PubMed 24353109Molnar GF, Sailer A, Gunraj CA, Cunic DI, Lang AE, Lozano AM, Moro E, Chen R. Changes in cortical excitability with thalamic deep brain stimulation. Neurology. 2005 Jun 14;64(11):1913-9. doi: 10.1212/01.WNL.0000163985.89444.DD.
PubMed 15955943Baker KB, Plow EB, Nagel S, Rosenfeldt AB, Gopalakrishnan R, Clark C, Wyant A, Schroedel M, Ozinga J 4th, Davidson S, Hogue O, Floden D, Chen J, Ford PJ, Sankary L, Huang X, Cunningham DA, DiFilippo FP, Hu B, Jones SE, Bethoux F, Wolf SL, Chae J, Machado AG. Cerebellar deep brain stimulation for chronic post-stroke motor rehabilitation: a phase I trial. Nat Med. 2023 Sep;29(9):2366-2374. doi: 10.1038/s41591-023-02507-0. Epub 2023 Aug 14.
PubMed 37580534Cooper IS, Upton AR, Amin I. Reversibility of chronic neurologic deficits. Some effects of electrical stimulation of the thalamus and internal capsule in man. Appl Neurophysiol. 1980;43(3-5):244-58. doi: 10.1159/000102263.
PubMed 6975064Phillips NI, Bhakta BB. Affect of deep brain stimulation on limb paresis after stroke. Lancet. 2000 Jul 15;356(9225):222-3. doi: 10.1016/s0140-6736(00)02487-9.
PubMed 10963204Franzini A, Cordella R, Nazzi V, Broggi G. Long-term chronic stimulation of internal capsule in poststroke pain and spasticity. Case report, long-term results and review of the literature. Stereotact Funct Neurosurg. 2008;86(3):179-83. doi: 10.1159/000120431. Epub 2008 Mar 12.
PubMed 18334861
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke
- ClinicalTrials.gov ID
- NCT06303869
- Acronym / sponsor ID
- STUDY22070043
- Conditions
- Stroke, Brain Disease, Central Nervous System Diseases, Nervous System Diseases, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Jorge Gonzalez-MartinezUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is designed to assess the assistive effects of DBS (i.e., immediate effects when the stimulation is turned ON) and obtain preliminary evidence for therapeutic effects (i.e., long-lasting effects with stimulation OFF). Researchers will 1) quantify the ability to recruit face muscles with electrical stimulation of the motor thalamus in patients with subcortical stroke, 2) quantify the ability to recruit arm and hand muscles with electrical stimulation of the motor thalamus in patients with subcortical stroke, and 3) verify if the delivery of DBS has effects on the central nervous system with clinical measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, open-label, descriptive, experimental.
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation of the Motor Thalamus | Experimental | Device: Deep Brain Stimulation (DBS) of the Motor ThalamusIndividuals who have speech and motor deficits due to a stroke. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
- Participants must not have any serious disease or disorder (ex. neurological condition other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) or cognitive impairments that could affect their ability to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain Stimulation (DBS) of the Motor ThalamusAll 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. | Device | Deep Brain Stimulation of the Motor Thalamus |
Primary outcome
Adverse Events
Time frame: 29 days
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
Time frame: Baseline, 2 weeks, 4 weeks, 6 months.
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.
8 secondary outcomes
Dysphagia
Time frame: 29 days
Hand dexterity
Time frame: 29 days.
Muscle weakness
Time frame: 29 days
Dexterity of Articulation AMRs
Time frame: 29 days
Dexterity of Articulation SMRs
Time frame: 29 days
Intelligibility of Speech
Time frame: 29 days
Spasticity
Time frame: 29 days
Range of Motion (ROM)
Time frame: 29 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- BackgroundHo, J. et al. TARGETED DEEP BRAIN STIMULATION OF THE MOTOR THALAMUS FACILITATES VOLUNTARY MOTOR CONTROL AFTER CORTICO-SPINAL LESIONS. medRxiv 2023-03 (2023).
- Background: PubMed 30683913Lozano AM, Lipsman N, Bergman H, Brown P, Chabardes S, Chang JW, Matthews K, McIntyre CC, Schlaepfer TE, Schulder M, Temel Y, Volkmann J, Krauss JK. Deep brain stimulation: current challenges and future directions. Nat Rev Neurol. 2019 Mar;15(3):148-160. doi: 10.1038/s41582-018-0128-2.
- Background: PubMed 24353109Plow EB, Machado A. Invasive neurostimulation in stroke rehabilitation. Neurotherapeutics. 2014 Jul;11(3):572-82. doi: 10.1007/s13311-013-0245-y.
- Background: PubMed 15955943Molnar GF, Sailer A, Gunraj CA, Cunic DI, Lang AE, Lozano AM, Moro E, Chen R. Changes in cortical excitability with thalamic deep brain stimulation. Neurology. 2005 Jun 14;64(11):1913-9. doi: 10.1212/01.WNL.0000163985.89444.DD.
- Background: PubMed 37580534Baker KB, Plow EB, Nagel S, Rosenfeldt AB, Gopalakrishnan R, Clark C, Wyant A, Schroedel M, Ozinga J 4th, Davidson S, Hogue O, Floden D, Chen J, Ford PJ, Sankary L, Huang X, Cunningham DA, DiFilippo FP, Hu B, Jones SE, Bethoux F, Wolf SL, Chae J, Machado AG. Cerebellar deep brain stimulation for chronic post-stroke motor rehabilitation: a phase I trial. Nat Med. 2023 Sep;29(9):2366-2374. doi: 10.1038/s41591-023-02507-0. Epub 2023 Aug 14.
- Background: PubMed 6975064Cooper IS, Upton AR, Amin I. Reversibility of chronic neurologic deficits. Some effects of electrical stimulation of the thalamus and internal capsule in man. Appl Neurophysiol. 1980;43(3-5):244-58. doi: 10.1159/000102263.
- Background: PubMed 10963204Phillips NI, Bhakta BB. Affect of deep brain stimulation on limb paresis after stroke. Lancet. 2000 Jul 15;356(9225):222-3. doi: 10.1016/s0140-6736(00)02487-9.
- Background: PubMed 18334861Franzini A, Cordella R, Nazzi V, Broggi G. Long-term chronic stimulation of internal capsule in poststroke pain and spasticity. Case report, long-term results and review of the literature. Stereotact Funct Neurosurg. 2008;86(3):179-83. doi: 10.1159/000120431. Epub 2008 Mar 12.
- Individual participant dataSharing planned: Yes. Data may be shared with other researchers for the purpose of data analysis and collaboration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jorge Gonzalez-Martinez, MD/PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation (DBS) of the Motor Thalamus in people with Stroke and Brain Disease, run by Jorge Gonzalez-Martinez at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cierra Clark, MS (240-441-4216, cic27@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 29 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06303869, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.