Traumatic Brain InjuryNCT07056348

Long-term Brain Stimulation of the Motor Ventral Thalamus (VOP/VIM) to Improve Motor Function

A study testing Deep Brain Stimulation (DBS) of the Motor Thalamus in people with Traumatic Brain Injury and Stroke, run by Jorge Gonzalez-Martinez at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Traumatic Brain Injury, Stroke, Brain Disease
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: 60 participants
Where: 1 siteUnited States
Study dates: 10 May 2022to 31 Dec 2030
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Movement disorder patients ≥18 years of age and < 80 years of age, who will be implanted with DBS for treatment of motor symptoms.
Subject has provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, where applicable, prior to any study-related procedures.

Who cannot join

History of seizure disorders
Vasovagal response history and loss of consciousness history
Severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator would impact participation in the study.
Any serious disease or disorder (e.g. cancer, severe cardiac or respiratory disease, neurological conditions other than current movement disorder) or cognitive impairments that could impair ability to participate in this study.
Females who are pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cierra Clark, MS contact

240-441-4216

cic27@pitt.edu

Elvira Pirondini, PhD contact

412-636-0595

elvirap@pitt.edu

United States1 site, 1 recruiting

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Cierra Clark, MS, 240-441-4216, cic27@pitt.edu
Elvira Pirondini, PhD, 412-636-0595, elvirap@pitt.edu
Recruiting

Other trials in United States

About this study

Official title: Chronic Stimulation of the Motor Ventral Thalamus (VOP/VIM) for Motor Control in Humans

This study aims to recruit patients already implanted with Deep Brain Stimulation (DBS) for movement disorders to complete tasks assessing parameters of motor output, speech, and swallowing functions, both with and without stimulation. DBS parameters would be adjusted prior to motor testing. Patients would then participate in multiple sessions performing contralateral upper extremity movement tasks measuring movement speed, grip strength, and strength modulation, facial movement, swallowing, and speech tasks.

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 facial and oropharyngeal muscles with electrical stimulation of the motor thalamus in patients with DBS for movement disorders, 2) quantify the ability to recruit arm and hand muscles with electrical stimulation of the motor thalamus in patients with DBS, and 3) verify if the delivery of DBS has effects on the central nervous system with clinical measures.

Conditions: Traumatic Brain Injury, Stroke, Brain Disease, Movement Disorders (Incl Parkinsonism), Central Nervous System Disease, Essential Tremor, Movement Disorders
Being tested: Deep Brain Stimulation (DBS) of the Motor Thalamus
Medical subject headings: Brain Injuries, Traumatic, Stroke, Brain Diseases, Movement Disorders, Central Nervous System Diseases, Essential Tremor

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 will undergo stimulation parameters tuning of deep brain stimulation electrode leads. All subjects will participate in a series of experiments to evaluate the stimulation effects on movement of face and upper extremities, swallowing, and speech abilities.

Study groups in NCT07056348
Study group	Role	What they receive
Deep Brain Stimulation of the Motor Thalamus	Experimental	Individuals with deep brain stimulation device implanted in the motor thalamus for movement disorders treatment who also sustain speech, swallowing, and motor deficits. Receives: Device: Deep Brain Stimulation (DBS) of the Motor Thalamus
Healthy Control Participants	No intervention	The investigators aim to include healthy control subjects who will complete the language and upper-limb tasks. The healthy subjects will not undergo any surgical procedures.

What is being measured

The primary outcome is the main question the study is designed to answer.

Upper Limb Motor Function - Hand Dexterity
The investigators will use the Box and Blocks Test (unit counts) and Brinkmann Test (unit counts) to measure hand dexterity. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in hand dexterity as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Measured: 2 years
Upper Limb Motor Function - Grip Strength
The investigators will use the Box and Blocks Test, Brinkmann Test, and force dynamometer tests to measure grip strength (Newton). These tests will combine weight and height into a single BMI measurement in kg/m^2. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in grip strength as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Measured: 2 years
Upper Limb Motor Function - Velocity
The investigators will use the Box and Blocks Test, Brinkmann Test, and force dynamometer tests to measure velocity (Newton per millisecond). These tests will combine weight and height into a single BMI measurement in kg/m^2. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in velocity as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Measured: 2 years
Upper Limb Motor Function - Strength Modulation
The investigators will use the Box and Blocks Test, Brinkmann Test, and force dynamometer tests to measure strength modulation (Newton). These tests will combine weight and height into a single BMI measurement in kg/m^2. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in modulation as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Measured: 2 years
Facial Muscle Motor Function
The investigators will use electromyography (EMG) testing to 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), measured in by calculation of Area-Under-the-Curve with units of uV^2/ms. These tests will combine weight and height into a single BMI measurement in kg/m^2. Based on the preliminary data, the investigators will consider the number of participants with an increase of 50% in ROM as a minimally acceptable improvement in muscle strength.
Measured: 2 years
Swallowing Function
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 the number of participants with 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: 2 years
Speech Intelligibility
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. Intelligibility is calculated as the percentage of words correctly identified in the single-word task, and as the percentage of correctly transcribed words and speech rate (in words per minute) in the sentence task. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 5% correctly transcribed to be minimally acceptable.
Measured: 2 years
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). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Measured: 2 years
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). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Measured: 2 years
Oral Motor Functions
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. Based on the preliminary data, the investigators will consider the number of participants with an improvement in severity level (e.g., from considerable to moderate severity, or a score of D to C) to be minimally acceptable.
Measured: 2 years
Respiration Capacity - Total Exhaled Volume
The investigators will measure pulmonary function and respiratory capacity by performing a spirometry test with focus on the forced vital capacity (FVC). The FVC is the total volume of air that can be forcefully exhaled after a maximal inhalation and this will be measured in liters (L). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 12% in the rate to be minimally acceptable.
Measured: 2 years
Respiration Capacity - Volume Exhaled
The investigators will measure pulmonary function and respiratory capacity by performing a spirometry test with focus on the volume exhaled in the first second (FEV1). The FEV1 is the volume of air exhaled in the first second of a forced exhalation and this will be measured in liters (L). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 12% in the rate to be minimally acceptable.
Measured: 2 years
Respiration Capacity - FEV1/FVC Ratio
The investigators will measure pulmonary function and respiratory capacity by performing a spirometry test with focus on ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC). The ratio is expressed as a unitless percentage. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 12% in the rate to be minimally acceptable.
Measured: 2 years
Oral Motor Strength
The investigators will use the Iowa Performance Instrument (IOPI) to measure motor strength of tongue and lip using maximum force and endurance. IOPI instrument measures force applied from oral cavity by kPa. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 202231 Dec 2030

First posted9 Jul 2025
Study start10 May 2022
Primary completion31 Dec 2030 (estimated)
Study completion31 Dec 2030 (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 Traumatic Brain InjuryStudies 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: Non-randomised
Intervention model: Parallel groups
Model description: Prospective, non-randomized, open-label, descriptive, experimental.
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07056348
Sponsor's protocol ID: STUDY21100020
Status last verified: Sep 2026
First submitted: 25 Jun 2025
Last updated: 18 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: All of the individual participant data collected during the trial, after deidentification, may be shared with other researchers for the purpose of data analysis and collaboration.

Publications

Franzini 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
Phillips 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 10963204
Cooper 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 6975064
Baker 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 37580534
Molnar 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 15955943
Plow EB, Machado A. Invasive neurostimulation in stroke rehabilitation. Neurotherapeutics. 2014 Jul;11(3):572-82. doi: 10.1007/s13311-013-0245-y.
PubMed 24353109
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 30683913
Ho JC, Grigsby EM, Damiani A, Liang L, Balaguer JM, Kallakuri S, Tang LW, Barrios-Martinez J, Karapetyan V, Fields D, Gerszten PC, Hitchens TK, Constantine T, Adams GM, Crammond DJ, Capogrosso M, Gonzalez-Martinez JA, Pirondini E. Potentiation of cortico-spinal output via targeted electrical stimulation of the motor thalamus. Nat Commun. 2024 Oct 1;15(1):8461. doi: 10.1038/s41467-024-52477-1.
PubMed 39353911

Interested in taking part?

Cierra Clark, MS

240-441-4216

cic27@pitt.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma

All Traumatic Brain Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Chronic Stimulation of the Motor Ventral Thalamus (VOP/VIM) for Motor Control in Humans
ClinicalTrials.gov ID: NCT07056348
Acronym / sponsor ID: STUDY21100020
Conditions: Traumatic Brain Injury, Stroke, Brain Disease, Movement Disorders (Incl Parkinsonism), Central Nervous System Disease, Essential Tremor, Movement Disorders
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Jorge Gonzalez-MartinezUniversity, hospital or other
Study start: 10 May 2022 (actual)
Primary completion: 31 Dec 2030 (estimated)
Study completion: 31 Dec 2030 (estimated)
First posted: 9 Jul 2025 (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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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 with deep brain stimulation device implanted in the motor thalamus for movement disorders treatment who also sustain speech, swallowing, and motor deficits.
Healthy Control Participants	No intervention	–The investigators aim to include healthy control subjects who will complete the language and upper-limb tasks. The healthy subjects will not undergo any surgical procedures.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Movement disorder patients ≥18 years of age and < 80 years of age, who will be implanted with DBS for treatment of motor symptoms.
Subject has provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, where applicable, prior to any study-related procedures.

Key exclusion criteria (5 listed)

History of seizure disorders
Vasovagal response history and loss of consciousness history
Severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator would impact participation in the study.
Any serious disease or disorder (e.g. cancer, severe cardiac or respiratory disease, neurological conditions other than current movement disorder) or cognitive impairments that could impair ability to participate in this study.
Females who are pregnant or breastfeeding.

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 will undergo stimulation parameters tuning of deep brain stimulation electrode leads. All subjects will participate in a series of experiments to evaluate the stimulation effects on movement of face and upper extremities, swallowing, and speech abilities.	Device	Deep Brain Stimulation of the Motor Thalamus

Primary outcome

Upper Limb Motor Function - Hand Dexterity
Time frame: 2 years
The investigators will use the Box and Blocks Test (unit counts) and Brinkmann Test (unit counts) to measure hand dexterity. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in hand dexterity as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Upper Limb Motor Function - Grip Strength
Time frame: 2 years
The investigators will use the Box and Blocks Test, Brinkmann Test, and force dynamometer tests to measure grip strength (Newton). These tests will combine weight and height into a single BMI measurement in kg/m^2. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in grip strength as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Upper Limb Motor Function - Velocity
Time frame: 2 years
The investigators will use the Box and Blocks Test, Brinkmann Test, and force dynamometer tests to measure velocity (Newton per millisecond). These tests will combine weight and height into a single BMI measurement in kg/m^2. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in velocity as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Upper Limb Motor Function - Strength Modulation
Time frame: 2 years
The investigators will use the Box and Blocks Test, Brinkmann Test, and force dynamometer tests to measure strength modulation (Newton). These tests will combine weight and height into a single BMI measurement in kg/m^2. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in modulation as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Facial Muscle Motor Function
Time frame: 2 years
The investigators will use electromyography (EMG) testing to 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), measured in by calculation of Area-Under-the-Curve with units of uV^2/ms. These tests will combine weight and height into a single BMI measurement in kg/m^2. Based on the preliminary data, the investigators will consider the number of participants with an increase of 50% in ROM as a minimally acceptable improvement in muscle strength.
Swallowing Function
Time frame: 2 years
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 the number of participants with 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.
Speech Intelligibility
Time frame: 2 years
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. Intelligibility is calculated as the percentage of words correctly identified in the single-word task, and as the percentage of correctly transcribed words and speech rate (in words per minute) in the sentence task. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 5% correctly transcribed to be minimally acceptable.
Dexterity of Articulation AMRs
Time frame: 2 years
The investigators will measure dexterity of articulation by alternating motion rates (AMRs) of the repetitive plosive sound (pah, tah, and kah). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Dexterity of Articulation SMRs
Time frame: 2 years
The investigators will measure dexterity of articulation by sequential motion rates (SMRs) of the repetitive plosive sound (pah, tah, and kah). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Oral Motor Functions
Time frame: 2 years
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. Based on the preliminary data, the investigators will consider the number of participants with an improvement in severity level (e.g., from considerable to moderate severity, or a score of D to C) to be minimally acceptable.
Respiration Capacity - Total Exhaled Volume
Time frame: 2 years
The investigators will measure pulmonary function and respiratory capacity by performing a spirometry test with focus on the forced vital capacity (FVC). The FVC is the total volume of air that can be forcefully exhaled after a maximal inhalation and this will be measured in liters (L). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 12% in the rate to be minimally acceptable.
Respiration Capacity - Volume Exhaled
Time frame: 2 years
The investigators will measure pulmonary function and respiratory capacity by performing a spirometry test with focus on the volume exhaled in the first second (FEV1). The FEV1 is the volume of air exhaled in the first second of a forced exhalation and this will be measured in liters (L). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 12% in the rate to be minimally acceptable.
Respiration Capacity - FEV1/FVC Ratio
Time frame: 2 years
The investigators will measure pulmonary function and respiratory capacity by performing a spirometry test with focus on ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC). The ratio is expressed as a unitless percentage. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 12% in the rate to be minimally acceptable.
Oral Motor Strength
Time frame: 2 years
The investigators will use the Iowa Performance Instrument (IOPI) to measure motor strength of tongue and lip using maximum force and endurance. IOPI instrument measures force applied from oral cavity by kPa. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.

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 18 Sep 2026.
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.
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 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 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 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 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 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 39353911Ho JC, Grigsby EM, Damiani A, Liang L, Balaguer JM, Kallakuri S, Tang LW, Barrios-Martinez J, Karapetyan V, Fields D, Gerszten PC, Hitchens TK, Constantine T, Adams GM, Crammond DJ, Capogrosso M, Gonzalez-Martinez JA, Pirondini E. Potentiation of cortico-spinal output via targeted electrical stimulation of the motor thalamus. Nat Commun. 2024 Oct 1;15(1):8461. doi: 10.1038/s41467-024-52477-1.
Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification, may be shared with other researchers for the purpose of data analysis and collaboration.

Related trials for Traumatic Brain Injury

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma

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.

Cierra Clark, MS contact

240-441-4216

cic27@pitt.edu

Elvira Pirondini, PhD contact

412-636-0595

elvirap@pitt.edu

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 Traumatic Brain Injury and Stroke, 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 2 inclusion and 5 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 18 Sep 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?

Upper Limb Motor Function - Hand Dexterity (time frame: 2 years). The study lists 14 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 NCT07056348, 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 18 Sep 2026.