Cerebellar AtaxiaIMPACTNCT07642856
Individualized Neuro-Modulation Paired With Cerebellar Therapy
A study testing Therapy in people with Cerebellar Ataxia and Cerebellar Diseases, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial summary
The purpose of this project is to evaluate feasibility and preliminary efficacy of pairing personalized transcranial direct current stimulation (tDCS) with individualized rehabilitation therapy in people with cerebellar damage. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebellar Ataxia, Cerebellar Diseases, Cerebellar Stroke
- What is being tested?
- Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 2 Dec 2032
- 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
- Age 18-75 years
- Males and Females
- Disorders that predominantly affect the cerebellum: damage from stroke, tumor or degeneration (genetic or non-genetic causes, congenital hypoplasia).
Who cannot join
- Diagnoses or impairments that interfere with task execution or data interpretation.
- Heart pacemaker or other MRI-incompatible implanted metal device
- Metallic foreign body in their eye or head
- Experience with severe claustrophobia
- Experience discomfort from the MRI scan, such as excessive heating of tattoos
- Seizures or history of seizure disorder
Show all 11Show fewer
- Alcohol or substance use disorder (self-report)
- Diagnosed history of severe psychiatric disorder such as depression, schizophrenia (self-report)
- Metallic foreign body in their eye or head (except the mouth e.g. dental fillings)
- Specific medications: tricyclic anti-depressants or neuroleptic medication
- Any medical condition (including orthopedic, pain, cardiopulmonary or other) that limits safe participation in exercise training
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
Motion Analysis Lab in the Kennedy Krieger Institute
Baltimore, Maryland, 21205
Anthony J Gonzalez, BS, 443-923-2716, gonzalezan@kennedykrieger.org
Amy J Bastian, PhD, PT
About this study
The purpose of this project is to evaluate feasibility and preliminary efficacy of pairing personalized transcranial direct current stimulation (tDCS) with individualized rehabilitation therapy in people with cerebellar damage.
Read the detailed description
Cerebellar damage causes debilitating ataxia affecting balance, coordination, speech, and cognition. Rehabilitation therapy is the main treatment for ataxia because pharmacological therapeutics are extremely limited. Non-invasive brain stimulation has shown promise in improving motor function and has an excellent safety profile. However, optimal stimulation sites and efficacy when combined with rehabilitation remain unclear.
We hypothesize that three weeks of intensive rehabilitation therapy paired with personalized transcranial direct current stimulation (tDCS) will produce greater functional improvements in people with cerebellar damage compared to therapy with sham stimulation.
This double-blind, randomized, sham-controlled trial will enroll participants with cerebellar damage. We will determine stimulation sites using multimodal neuroimaging and electric field modeling and then check their response to stimulation. If they show MRI response to stimulation and it is well-tolerated, they will be eligible to receive 30 hours of training (one hour, twice daily), with active or sham tDCS during one of the daily sessions Primary outcomes are the Scale for Assessment and Rating of Cerebellar Ataxia (SARA) and Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia), assessed pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
This research addresses a critical gap in treatment options for cerebellar ataxia by testing whether personalized neuromodulation enhances rehabilitation outcomes.
- Being tested
- Therapy
- Keywords
- non-invasive brain stimulation, rehabilitation, physical therapy
- Medical subject headings
- Cerebellar Ataxia, Cerebellar Diseases, Cerebellar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TherapyBehavioural
Each participant will choose a domain that they would like to focus on. Choices are: 1) walking and balance control, 2) hand dexterity and arm control, or 3) speech articulation, prosody, and intelligibility.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation combined with therapy. | Experimental | Once a stimulation site is determined, subjects will receive 20 minutes of active tDCS stimulation daily. Subjects will also receive one hour of therapy, twice daily. Therapy will be individualized to each subject and, will encompass three domains; 1) walking and balance control, 2) hand dexterity and arm control, 3)speech articulation, prosody, and intelligibility. Subjects will complete up to 30 therapy sessions. Receives: Behavioral: Therapy |
| Sham stimulation combined with therapy. | Sham comparator | Once a stimulation site is determined, subjects will receive 20 minutes of sham tDCS stimulation daily. Subjects will also receive one hour of therapy, twice daily. Therapy will be individualized to each subject and, will encompass three domains; 1) walking and balance control, 2) hand dexterity and arm control, 3)speech articulation, prosody, and intelligibility. Subjects will complete up to 30 therapy sessions. Receives: Behavioral: Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for the Assessment and Rating of Ataxia (SARA)
The SARA is a tool for assessing ataxia. SARA is an 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia). The scores are based on patient performance of: gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements, heel-shin slide.
Measured: Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
Patient-Reported Outcome Measure of Ataxia
The PROM-Ataxia is a self reported questionnaire used by researchers to evaluate the daily impact and progression of cerebellar ataxia directly from the patient's perspective. The questionnaire encompasses 70 total items within 3 main domains: 1) Physical: Gait, manual dexterity, swallowing (dysphagia), and visual/ocular motor control. 2) Activities of Daily Living (ADL): Managing household chores, employment, driving, and self-care. 3)Mental: Mood, anxiety, motivation, and cognitive tasks (e.g., multitasking and comprehension).
Measured: Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion2 Jul 2032 (estimated)
- Study completion2 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar AtaxiaStudies 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
- Parallel groups
- Model description
- All participants will receive exercise therapy. Some will receive active transcranial direct current stimulation and some will receive sham stimulation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Once Upon a Time Foundation
- Responsible party
- Principal investigator, Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Amy J Bastian, PhD, PT, Principal investigator, Motion Analysis Lab in the Kennedy Krieger Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642856
- Sponsor's protocol ID
- IRB00519286
- Acronym
- IMPACT
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Neuro-Modulation Paired With Cerebellar Therapy
- ClinicalTrials.gov ID
- NCT07642856
- Acronym / sponsor ID
- IMPACT / IRB00519286
- Keywords
- non-invasive brain stimulation, rehabilitation, physical therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- Once Upon a Time Foundation
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 2 Jul 2032 (estimated)
- Study completion
- 2 Dec 2032 (estimated)
- First posted
- 11 Jun 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 purpose of this project is to evaluate feasibility and preliminary efficacy of pairing personalized transcranial direct current stimulation (tDCS) with individualized rehabilitation therapy in people with cerebellar damage.
Detailed description
Cerebellar damage causes debilitating ataxia affecting balance, coordination, speech, and cognition. Rehabilitation therapy is the main treatment for ataxia because pharmacological therapeutics are extremely limited. Non-invasive brain stimulation has shown promise in improving motor function and has an excellent safety profile. However, optimal stimulation sites and efficacy when combined with rehabilitation remain unclear.
We hypothesize that three weeks of intensive rehabilitation therapy paired with personalized transcranial direct current stimulation (tDCS) will produce greater functional improvements in people with cerebellar damage compared to therapy with sham stimulation.
This double-blind, randomized, sham-controlled trial will enroll participants with cerebellar damage. We will determine stimulation sites using multimodal neuroimaging and electric field modeling and then check their response to stimulation. If they show MRI response to stimulation and it is well-tolerated, they will be eligible to receive 30 hours of training (one hour, twice daily), with active or sham tDCS during one of the daily sessions Primary outcomes are the Scale for Assessment and Rating of Cerebellar Ataxia (SARA) and Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia), assessed pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
This research addresses a critical gap in treatment options for cerebellar ataxia by testing whether personalized neuromodulation enhances rehabilitation outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All participants will receive exercise therapy. Some will receive active transcranial direct current stimulation and some will receive sham stimulation.
| Arm | Type | Receives |
|---|---|---|
| Active stimulation combined with therapy. | Experimental | Behavioral: TherapyOnce a stimulation site is determined, subjects will receive 20 minutes of active tDCS stimulation daily. Subjects will also receive one hour of therapy, twice daily. Therapy will be individualized to each subject and, will encompass three domains; 1) walking and balance control, 2) hand dexterity and arm control, 3)speech articulation, prosody, and intelligibility. Subjects will complete up to 30 therapy sessions. |
| Sham stimulation combined with therapy. | Sham comparator | Behavioral: TherapyOnce a stimulation site is determined, subjects will receive 20 minutes of sham tDCS stimulation daily. Subjects will also receive one hour of therapy, twice daily. Therapy will be individualized to each subject and, will encompass three domains; 1) walking and balance control, 2) hand dexterity and arm control, 3)speech articulation, prosody, and intelligibility. Subjects will complete up to 30 therapy sessions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years
- Males and Females
- Disorders that predominantly affect the cerebellum: damage from stroke, tumor or degeneration (genetic or non-genetic causes, congenital hypoplasia).
Key exclusion criteria (11 listed)
- Diagnoses or impairments that interfere with task execution or data interpretation.
- Heart pacemaker or other MRI-incompatible implanted metal device
- Metallic foreign body in their eye or head
- Experience with severe claustrophobia
- Experience discomfort from the MRI scan, such as excessive heating of tattoos
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 |
|---|---|---|
| TherapyEach participant will choose a domain that they would like to focus on. Choices are: 1) walking and balance control, 2) hand dexterity and arm control, or 3) speech articulation, prosody, and intelligibility. | Behavioural | Active stimulation combined with therapy., Sham stimulation combined with therapy. |
Primary outcome
Scale for the Assessment and Rating of Ataxia (SARA)
Time frame: Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
The SARA is a tool for assessing ataxia. SARA is an 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia). The scores are based on patient performance of: gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements, heel-shin slide.
Patient-Reported Outcome Measure of Ataxia
Time frame: Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
The PROM-Ataxia is a self reported questionnaire used by researchers to evaluate the daily impact and progression of cerebellar ataxia directly from the patient's perspective. The questionnaire encompasses 70 total items within 3 main domains: 1) Physical: Gait, manual dexterity, swallowing (dysphagia), and visual/ocular motor control. 2) Activities of Daily Living (ADL): Managing household chores, employment, driving, and self-care. 3)Mental: Mood, anxiety, motivation, and cognitive tasks (e.g., multitasking and comprehension).
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 11 Jun 2026.
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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An Open-Label Study of CTI-1601 in Subjects With Friedreich's Ataxia
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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.
Amy J Bastian, PhD, PT principal investigator
Motion Analysis Lab in the Kennedy Krieger Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy in people with Cerebellar Ataxia and Cerebellar Diseases, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. 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 3 inclusion and 11 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 11 Jun 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 Derek J Eversley, BS (443-923-2716, eversley@kennedykrieger.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale for the Assessment and Rating of Ataxia (SARA) (time frame: Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.). 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 11 Jun 2026.