Cerebellar StrokeNCT07838961
Brain Stimulation to Improvement After Cerebellar Damage
A study testing Transcranial Magnetic Stimulation in people with Cerebellar Stroke and Autoimmune Cerebellar Disorders, run by George Wittenberg at 1 site in United States.
Trial summary
The work will examine the mechanisms and potential therapeutic effects of transcranial magnetic stimulation on upper-limb sensorimotor function in individuals with cerebellar dysfunction, including those with damage due to stroke or autoimmune disease. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebellar Stroke, Autoimmune Cerebellar Disorders
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2028
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-100 years old,
- native English speakers,
- medically stable to participate in the study.
- For those with cerebellar disorders:
- presenting with a cerebellar disorder including cerebellar stroke
- cerebellar disorder onset at least 2 weeks before enrollment.
Who cannot join
- are unable to give consent,
- have contractures, orthopedic problems, or other impairments that would interfere with the use of the robot or limit the range of joint motion in the potential study arm,
- presence of medical condition or implant that prevents safe administration of stimulation (history of seizures, and/or taking any of the following medications: lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), topiramate (Topamax), phenytoin (Dilantin), arbamazepine (Tegretol), valproic acid (Depakote), or phenobarbital (Barbita, Luminal, Solfoton).
- have any factor that precludes participation in a magnetic resonance imaging (MRI) session (e.g. ferrous metal in the body), or
- have a medical condition or physical impairment precluding the ability of the participant to complete the required testing.
- are pregnant
- Control participants will be excluded for the following condition:
- have self-reported history of neurological injury or a developmental disorder
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
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Neuromodulation of Cerebellar Circuitry
The work will examine the mechanisms and potential therapeutic effects of transcranial magnetic stimulation on upper-limb sensorimotor function in individuals with cerebellar dysfunction, including those with damage due to stroke or autoimmune disease.
The study team will work toward a goal of non-invasive stimulation-based neuromodulatory interventions for cerebellar disorders using a closely integrated, clinically oriented cross-species approach. There will be a related study in nonhuman primates.
Read the detailed description
Although diseases of the cerebellum can compromise quality of life, their treatment has received less research and clinical attention than diseases of other parts of the nervous system, such as the cerebral cortex and the spinal cord. The vision is a cerebellar prosthesis: a surgically implanted closed-loop neuromodulation system that can alleviate the symptoms of cerebellar dysfunction. Cerebellar disorders are varied, as are the opportunities for treatment. This study focuses on cerebellar disorders that impair arm and hand function as an entry point to study mechanisms of disability and treatment modalities. This first begins with exploring neuromodulation in the form of noninvasive transcranial stimulation.
Aim 1: Use noninvasive neuromodulation to improve upper-limb dysfunction associated with cerebellar disorders.
Deficits associated with cerebellar disorders can be subtle, yet persistent and frustrating for those who experience them. Motor adaptation is a well-established cerebellum-dependent process and remains an important entry point for broader effort to understand cerebellar dysfunction and develop treatment strategies. Upper-limb dysfunction in cerebellar disorders may also reflect impairments in sensory processing, motor control, and motor learning, as well as disruption of broader cerebello-cerebral networks, including posterior parietal cortical (PPC) regions involved in sensorimotor integration and movement updating. Working hypotheses: 1. Impaired sensorimotor performance, including deficits in motor learning during a fine-grained reaching task, will be observed in individuals with cerebellar disorders, 2. These impairments will be associated with damage to sensorimotor regions of the cerebellum that will serve as future targets for an NHP stroke model, and with disruption to a functionally connected network of cerebral sensorimotor regions including PPC, 3. Intermittent theta burst stimulation (iTBS) can modulate cerebro-cerebellar circuit-level function to healthier states, improving motor control and implicit adaptation during reaching tasks.
Aim 1 will (i) characterize impaired reaching in individuals with cerebellar disorders, (ii) identify neuroanatomical correlates of impaired reaching, and (iii) test whether iTBS can improve reaching abilities after cerebellar dysfunction. A rigorous behavioral battery of assessments are designed to assess sensory function, motor control, and motor learning during reaching-related tasks.
- Conditions
- Cerebellar Stroke, Autoimmune Cerebellar Disorders
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- motor, transcranial magnetic stimulation, cerebellum, stroke, movement disorders
- Medical subject headings
- Stroke, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Stimulation of continuous theta burst stimulation at 80% of resting motor threshold over the region targeted for modulation after behavioral testing, with resting of behavior afterwards.
| Study group | Role | What they receive |
|---|---|---|
| Parietal Brain Stimulation | Experimental | Brain stimulation will be applied to the parietal reach region. Receives: Device: Transcranial Magnetic Stimulation |
| Cerebellar brain stimulation | Experimental | Theta burst TMS stimulation will be applied over the cerebellum Receives: Device: Transcranial Magnetic Stimulation |
| Parietal Midline Brain stimulation | Sham comparator | Theta burst stimulation will be applied over the parietal midline Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Assessments with KINARM Robot
In the arm position matching task, the robot will move one arm to a target location, and participants will match the perceived position with the opposite arm (~50 trials per assessment, ~10 minutes). In the alternating reaching task, participants will make rapid alternating reaches between targets while keeping the movement within a visually defined channel or bounded path (~80 reaches per assessment, ~10 minutes). In the clamped feedback reaching task, participants will complete brief sequences of center-out reaches designed to measure single-trial adaptation. Each sequence will include no-feedback reaches surrounding a trial with experimentally manipulated cursor feedback. During clamped-feedback trials, the cursor will move along a fixed path relative to the target, independent of the participant's actual hand direction. Adaptation will be estimated from changes in reach direction on subsequent no-feedback reaches (~120 total trials per assessment, ~15 minutes).
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Different stimulation conditions on different days
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, George Wittenberg, University of Pittsburgh
- Investigators
- Jorge A González-Martinez, MD, PhD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838961
- Sponsor's protocol ID
- STUDY26050032
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Anonymized imaging, clinical and behavioral measurements
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation of Cerebellar Circuitry
- ClinicalTrials.gov ID
- NCT07838961
- Acronym / sponsor ID
- STUDY26050032
- Conditions
- Cerebellar Stroke, Autoimmune Cerebellar Disorders
- Keywords
- motor, transcranial magnetic stimulation, cerebellum, stroke, movement disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- George WittenbergUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Sep 2026 (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 work will examine the mechanisms and potential therapeutic effects of transcranial magnetic stimulation on upper-limb sensorimotor function in individuals with cerebellar dysfunction, including those with damage due to stroke or autoimmune disease.
The study team will work toward a goal of non-invasive stimulation-based neuromodulatory interventions for cerebellar disorders using a closely integrated, clinically oriented cross-species approach. There will be a related study in nonhuman primates.
Detailed description
Although diseases of the cerebellum can compromise quality of life, their treatment has received less research and clinical attention than diseases of other parts of the nervous system, such as the cerebral cortex and the spinal cord. The vision is a cerebellar prosthesis: a surgically implanted closed-loop neuromodulation system that can alleviate the symptoms of cerebellar dysfunction. Cerebellar disorders are varied, as are the opportunities for treatment. This study focuses on cerebellar disorders that impair arm and hand function as an entry point to study mechanisms of disability and treatment modalities. This first begins with exploring neuromodulation in the form of noninvasive transcranial stimulation.
Aim 1: Use noninvasive neuromodulation to improve upper-limb dysfunction associated with cerebellar disorders.
Deficits associated with cerebellar disorders can be subtle, yet persistent and frustrating for those who experience them. Motor adaptation is a well-established cerebellum-dependent process and remains an important entry point for broader effort to understand cerebellar dysfunction and develop treatment strategies. Upper-limb dysfunction in cerebellar disorders may also reflect impairments in sensory processing, motor control, and motor learning, as well as disruption of broader cerebello-cerebral networks, including posterior parietal cortical (PPC) regions involved in sensorimotor integration and movement updating. Working hypotheses: 1. Impaired sensorimotor performance, including deficits in motor learning during a fine-grained reaching task, will be observed in individuals with cerebellar disorders, 2. These impairments will be associated with damage to sensorimotor regions of the cerebellum that will serve as future targets for an NHP stroke model, and with disruption to a functionally connected network of cerebral sensorimotor regions including PPC, 3. Intermittent theta burst stimulation (iTBS) can modulate cerebro-cerebellar circuit-level function to healthier states, improving motor control and implicit adaptation during reaching tasks.
Aim 1 will (i) characterize impaired reaching in individuals with cerebellar disorders, (ii) identify neuroanatomical correlates of impaired reaching, and (iii) test whether iTBS can improve reaching abilities after cerebellar dysfunction. A rigorous behavioral battery of assessments are designed to assess sensory function, motor control, and motor learning during reaching-related tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Different stimulation conditions on different days
| Arm | Type | Receives |
|---|---|---|
| Parietal Brain Stimulation | Experimental | Device: Transcranial Magnetic StimulationBrain stimulation will be applied to the parietal reach region. |
| Cerebellar brain stimulation | Experimental | Device: Transcranial Magnetic StimulationTheta burst TMS stimulation will be applied over the cerebellum |
| Parietal Midline Brain stimulation | Sham comparator | Device: Transcranial Magnetic StimulationTheta burst stimulation will be applied over the parietal midline |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-100 years old,
- native English speakers,
- medically stable to participate in the study.
- presenting with a cerebellar disorder including cerebellar stroke
- cerebellar disorder onset at least 2 weeks before enrollment.
Key exclusion criteria (8 listed)
- are unable to give consent,
- have contractures, orthopedic problems, or other impairments that would interfere with the use of the robot or limit the range of joint motion in the potential study arm,
- presence of medical condition or implant that prevents safe administration of stimulation (history of seizures, and/or taking any of the following medications: lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), topiramate (Topamax), phenytoin (Dilantin), arbamazepine (Tegretol), valproic acid (Depakote), or phenobarbital (Barbita, Luminal, Solfoton).
- have any factor that precludes participation in a magnetic resonance imaging (MRI) session (e.g. ferrous metal in the body), or
- have a medical condition or physical impairment precluding the ability of the participant to complete the required testing.
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 |
|---|---|---|
| Transcranial Magnetic StimulationStimulation of continuous theta burst stimulation at 80% of resting motor threshold over the region targeted for modulation after behavioral testing, with resting of behavior afterwards. | Device | Cerebellar brain stimulation, Parietal Brain Stimulation, Parietal Midline Brain stimulation |
Primary outcome
Motor Assessments with KINARM Robot
Time frame: From enrollment to the end of treatment at 8 weeks
In the arm position matching task, the robot will move one arm to a target location, and participants will match the perceived position with the opposite arm (~50 trials per assessment, ~10 minutes). In the alternating reaching task, participants will make rapid alternating reaches between targets while keeping the movement within a visually defined channel or bounded path (~80 reaches per assessment, ~10 minutes). In the clamped feedback reaching task, participants will complete brief sequences of center-out reaches designed to measure single-trial adaptation. Each sequence will include no-feedback reaches surrounding a trial with experimentally manipulated cursor feedback. During clamped-feedback trials, the cursor will move along a fixed path relative to the target, independent of the participant's actual hand direction. Adaptation will be estimated from changes in reach direction on subsequent no-feedback reaches (~120 total trials per assessment, ~15 minutes).
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 24 Sep 2026.
- Individual participant dataSharing planned: Yes. Anonymized imaging, clinical and behavioral measurements
Related trials for Cerebellar Stroke
Not yet recruiting
Dentate-Targeted Temporal Interference Stimulation for Post-Stroke Dysphagia
Deglutition Disorders, Ischemic Stroke
Not yet recruiting
Effect of Cerebellar Fastigial Nucleus Stimulation Combined With Sling Exercise on Motor Function in Hemiplegic Stroke Patients
Stroke
Recruiting
Imaging Speech in Neurotypical Adults and Individuals With Cerebellar Stroke
Stroke, Cerebellum
Recruiting
Individualized Neuro-Modulation Paired With Cerebellar Therapy
Cerebellar Ataxia, Cerebellar Diseases
Recruiting
Effects of a Neurorehabilitation Program Based on CIMT and Non-invasive Neuromodulation Through C-tDCS on the Recovery of Paretic Upper Limb Function, Quality of Life, and Therapeutic Alliance in Women From the Araucanía Region Who Suffered a Stroke (CIMT + tDCS).
Stroke
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 A González-Martinez, MD, PhD study director
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 Transcranial Magnetic Stimulation in people with Cerebellar Stroke and Autoimmune Cerebellar Disorders, run by George Wittenberg 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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 24 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. Some participants in this study may receive a placebo. 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 George F Wittenberg, MD, PhD (412-648-4178, GeoWitt@Pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Assessments with KINARM Robot (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2026.