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NCT Number: NCT07642856

Individualized Neuro-Modulation Paired With Cerebellar Therapy

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Motion Analysis Lab in the Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location status: Recruiting

Location contact

Amy J Bastian, PhD, PT

PRINCIPAL_INVESTIGATOR

Anthony J Gonzalez, BS

CONTACT

[email protected]

443-923-2716

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Therapy

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Anthony J Gonzalez, BS

CONTACT

[email protected]

443-923-2716

Derek J Eversley, BS

CONTACT

[email protected]

443-923-2716

Sponsors and collaborators

Lead sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Other

Collaborators

  • Once Upon a Time Foundation

Registry information

Acronym: IMPACT

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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