Spinocerebellar Ataxia (SCA)NCT07325487
Interposed Nucleus aDBS for Ataxia
A study testing Deep Brain Stimulation in people with Spinocerebellar Ataxia (SCA) and Spinocerebellar Ataxia Type 6, run by University of Florida at 1 site in United States.
Trial summary
This is a single-center, open-label study designed to evaluate the feasibility, safety, and preliminary efficacy of cerebellar adaptive deep brain stimulation (aDBS) in adults with spinocerebellar ataxia type 6 (SCA6). A total of 5 participants will be enrolled. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Spinocerebellar Ataxia (SCA), Spinocerebellar Ataxia Type 6
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2026to Jun 2031
- 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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of SCA6 by a movement disorders specialist following established criteria recommended by the Movement Disorders Society
- A positive genetic test for SCA6
- A total score ≥ 8 on the Scale of the Assessment and Rating of Ataxia (SARA) rating scale
- Ability to walk with or without support (score <8 on the 'gait' subsection of the SARA rating scale)
- Age ≥ 21 years and <89 years
- Ability to give informed consent for the study
- Ability to understand the study protocol
Who cannot join
- Inability or unwillingness to comply with the study protocol
- History of previously implanted neurostimulators, pacemakers, defibrillators, or metallic head implants
- Severe cognitive impairment or dementia, defined as a score <21 on the Montreal Cognitive Assessment (MOCA)
- Evidence of ataxia due to other etiologies, including but not limited to:
- Genetic/inherited disorders other than SCA6
- Acquired causes: traumatic brain injury, multiple sclerosis, paraneoplastic cerebellar degeneration, infections or post-infectious cerebellitis, autoimmune ataxias (e.g., anti-GAD, gluten ataxia)
Show all 16Show fewer
- Toxic/metabolic causes: alcoholic cerebellar degeneration, vitamin deficiencies
- Structural, vascular, or neoplastic causes: cerebellar stroke, tumors, congenital malformations
- Suspected multiple system atrophy-cerebellar type (MSA-C)
- Presence of active and untreated psychiatric illness, severe depression (Beck Depression Inventory ≥ 21), or personality disorder at the discretion of the study team
- Coagulopathy, uncontrolled epilepsy, or other medical conditions that are considered to place the patient at elevated risk for surgical complications
- Presence of a concomitant medical condition that, in the investigator's opinion, may interfere with the study participation or gait/balance, for example, severe arthritis
- Requirement of diathermy, electroconvulsive therapy, or transcranial magnetic stimulation
- Pregnancy or lactation
- Active suicidal ideation, defined as fined as a "Yes" response to questions #2-5 within the past one month on the Columbia Suicide Severity Rating Scale, C-SSRS
- Refractory epilepsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emily Rafferty, PhD contact
United States1 site, 1 recruiting
- Recruiting
Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, 32608
Julia C Gonzalez, BA, 352-265-0111 ext. 32495, Julia.Gonzalez@neurology.ufl.edu
Emily Rafferty, PhD, Emily.Rafferty@neurology.ufl.edu
About this study
Official title: Adaptive Deep Brain Stimulation Targeting the Interposed Nucleus to Treat Spinocerebellar Ataxia
This is a single-center, open-label study designed to evaluate the feasibility, safety, and preliminary efficacy of cerebellar adaptive deep brain stimulation (aDBS) in adults with spinocerebellar ataxia type 6 (SCA6). A total of 5 participants will be enrolled.
Participants will undergo surgical implantation of deep brain stimulation (DBS) leads targeting the motor interposed nucleus of the cerebellum. The leads will be connected to one or two implantable pulse generators capable of delivering stimulation to deep brain structures and recording neural activity.
Read more
Participants will complete up to 18 in-person study visits over a 24-month follow-up period. During these visits, neural signals will be recorded under varying behavioral tasks and stimulation conditions.
Early study visits will be used to identify optimal stimulation parameters and neural biomarkers associated with disease state. These biomarkers will subsequently be used to implement adaptive DBS, in which stimulation amplitude is automatically adjusted in response to recorded neural activity.
Study outcomes will include assessments of safety and feasibility of cerebellar aDBS, as well as preliminary evaluation of its effects on clinical measures.
- Being tested
- Deep Brain Stimulation
- Keywords
- SCA6, Spinocerebellar Ataxia, adaptive deep brain stimulation, aDBS, Spinocerebellar Ataxia Type 6, DBS, deep brain stimulation
- Medical subject headings
- Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Also called Medtronic Percept
This device will be surgically implanted into the interposed nucleus of the cerebellum.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Deep Brain Stimulation (aDBS) | Experimental | Participants will undergo surgical implantation of deep brain stimulation (DBS) leads targeting the motor interposed nucleus of the cerebellum. Approximately one month after implantation, participants will begin conventional DBS (cDBS) programming to identify optimal stimulation parameters, including amplitude, contact configuration, frequency, and pulse width, and to assess stimulation-related adverse effects and device function.
Approximately nine months after implantation, stimulation settings will be transitioned to adaptive DBS (aDBS), in which stimulation amplitude is automatically adjusted based on recorded neural activity. Adaptive DBS will be used to evaluate the feasibility, safety, and tolerability of cerebellar aDBS.
Clinical outcomes, symptoms, and potential side effects will be assessed throughout the study using participant self-reports, validated clinical rating scales, and wearable devices to collect movement and sleep data. Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The identification of a physiological signal to use as the aDBS feedback signal
Local field potentials (LFP) will be recorded in the clinic as well as chronically at home. These recordings will be analyzed to identify electrophysiological markers of disease states and therapeutic effects.
Measured: From baseline through study completion, about 2 years.
The incidence of unexpected adverse events and serious adverse events with aDBS compared to baseline
Adverse events are monitored the entire time subject is enrolled in study. Unexpected and serious adverse events from baseline through study completion, about 2 years, is a primary endpoint.
Measured: From baseline through study completion, about 2 years.
Secondary outcomes (3)
The Upright Balance Assessment measured by force plate parameters
The Upright Balance Assessment is designed to evaluate walking and balance.
Measured: From baseline through study completion, about 2 years.
The Scale for the Assessment and Rating of Ataxia (SARA)
The Scale for the Assessment and Rating of Ataxia (SARA) is an 8-item performance based scale used to determine the severity of ataxia. Scoring ranges from 0 to 40, with a higher score indicating greater ataxia severity.
Measured: From baseline through study completion, about 2 years.
The Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia)
The Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia) is a 70-item scale divided into three domains of patient experiences assessing physical function, activities of daily living (ADL), and mental health. Scores range from 0 to 280, with a higher score indicating more severe symptoms and poorer quality of life.
Measured: From baseline through study completion, about 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start2 Jun 2026
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinocerebellar Ataxia (SCA)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Raynor Cerebellum Project
- Responsible party
- Sponsor
- Investigators
- Coralie de Hemptinne, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325487
- Sponsor's protocol ID
- IRB202501191
- Status last verified
- Jun 2026
- First submitted
- 5 Jan 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Deep Brain Stimulation Targeting the Interposed Nucleus to Treat Spinocerebellar Ataxia
- ClinicalTrials.gov ID
- NCT07325487
- Acronym / sponsor ID
- IRB202501191
- Keywords
- SCA6, Spinocerebellar Ataxia, adaptive deep brain stimulation, aDBS, Spinocerebellar Ataxia Type 6, DBS, deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Raynor Cerebellum Project
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 8 Jan 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.
This is a single-center, open-label study designed to evaluate the feasibility, safety, and preliminary efficacy of cerebellar adaptive deep brain stimulation (aDBS) in adults with spinocerebellar ataxia type 6 (SCA6). A total of 5 participants will be enrolled.
Participants will undergo surgical implantation of deep brain stimulation (DBS) leads targeting the motor interposed nucleus of the cerebellum. The leads will be connected to one or two implantable pulse generators capable of delivering stimulation to deep brain structures and recording neural activity.
Participants will complete up to 18 in-person study visits over a 24-month follow-up period. During these visits, neural signals will be recorded under varying behavioral tasks and stimulation conditions.
Early study visits will be used to identify optimal stimulation parameters and neural biomarkers associated with disease state. These biomarkers will subsequently be used to implement adaptive DBS, in which stimulation amplitude is automatically adjusted in response to recorded neural activity.
Study outcomes will include assessments of safety and feasibility of cerebellar aDBS, as well as preliminary evaluation of its effects on clinical measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive Deep Brain Stimulation (aDBS) | Experimental | Device: Deep Brain StimulationParticipants will undergo surgical implantation of deep brain stimulation (DBS) leads targeting the motor interposed nucleus of the cerebellum. Approximately one month after implantation, participants will begin conventional DBS (cDBS) programming to identify optimal stimulation parameters, including amplitude, contact configuration, frequency, and pulse width, and to assess stimulation-related adverse effects and device function. Approximately nine months after implantation, stimulation settings will be transitioned to adaptive DBS (aDBS), in which stimulation amplitude is automatically adjusted based on recorded neural activity. Adaptive DBS will be used to evaluate the feasibility, safety, and tolerability of cerebellar aDBS. Clinical outcomes, symptoms, and potential side effects will be assessed throughout the study using participant self-reports, validated clinical rating scales, and wearable devices to collect movement and sleep data. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A diagnosis of SCA6 by a movement disorders specialist following established criteria recommended by the Movement Disorders Society
- A positive genetic test for SCA6
- A total score ≥ 8 on the Scale of the Assessment and Rating of Ataxia (SARA) rating scale
- Ability to walk with or without support (score <8 on the 'gait' subsection of the SARA rating scale)
- Age ≥ 21 years and <89 years
Key exclusion criteria (16 listed)
- Inability or unwillingness to comply with the study protocol
- History of previously implanted neurostimulators, pacemakers, defibrillators, or metallic head implants
- Severe cognitive impairment or dementia, defined as a score <21 on the Montreal Cognitive Assessment (MOCA)
- Evidence of ataxia due to other etiologies, including but not limited to:
- Presence of active and untreated psychiatric illness, severe depression (Beck Depression Inventory ≥ 21), or personality disorder at the discretion of the study team
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 StimulationAlso: Medtronic PerceptThis device will be surgically implanted into the interposed nucleus of the cerebellum. | Device | Adaptive Deep Brain Stimulation (aDBS) |
Primary outcome
The identification of a physiological signal to use as the aDBS feedback signal
Time frame: From baseline through study completion, about 2 years.
Local field potentials (LFP) will be recorded in the clinic as well as chronically at home. These recordings will be analyzed to identify electrophysiological markers of disease states and therapeutic effects.
The incidence of unexpected adverse events and serious adverse events with aDBS compared to baseline
Time frame: From baseline through study completion, about 2 years.
Adverse events are monitored the entire time subject is enrolled in study. Unexpected and serious adverse events from baseline through study completion, about 2 years, is a primary endpoint.
3 secondary outcomes
The Upright Balance Assessment measured by force plate parameters
Time frame: From baseline through study completion, about 2 years.
The Scale for the Assessment and Rating of Ataxia (SARA)
Time frame: From baseline through study completion, about 2 years.
The Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia)
Time frame: From baseline through study completion, about 2 years.
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 20 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Emily Rafferty, PhD contact
Coralie de Hemptinne, PhD principal investigator
University of Florida
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 in people with Spinocerebellar Ataxia (SCA) and Spinocerebellar Ataxia Type 6, run by University of Florida 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 7 inclusion and 16 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 20 Jul 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 Julia C Gonzalez, BA ((352) 265-0111 ext. 32495, Julia.Gonzalez@neurology.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The identification of a physiological signal to use as the aDBS feedback signal (time frame: From baseline through study completion, about 2 years.). 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?
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 20 Jul 2026.