Individualized Neuro-Modulation Paired With Cerebellar Therapy (IMPACT)

June 8, 2026 updated by: Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Motion Analysis Lab in the Kennedy Krieger Institute
        • Contact:
        • Principal Investigator:
          • Amy J Bastian, PhD, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active stimulation combined with therapy.
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.
Behavioral: Therapy
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.
Sham Comparator: Sham stimulation combined with therapy.
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.
Behavioral: Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
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).
Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Once Upon a Time Foundation

Investigators

  • Principal Investigator: Amy J Bastian, PhD, PT, Motion Analysis Lab in the Kennedy Krieger Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

July 2, 2032

Study Completion (Estimated)

December 2, 2032

Study Registration Dates

First Submitted

June 8, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00519286

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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