Neuro-Modulation and Therapy for Cerebellar Disorders
(IMPACT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Amy J Bastian, PhD, PT
Principal Investigator
Motion Analysis Lab in the Kennedy Krieger Institute
Are You a Good Fit for This Trial?
This trial is for people with cerebellar disorders or damage, such as ataxia, tumors, stroke, or related diseases. Participants must have cerebellar problems and meet other basic health requirements set by the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intensive rehabilitation therapy paired with personalized transcranial direct current stimulation (tDCS) for three weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Individualized Rehabilitation Therapy
- Transcranial Direct Current Stimulation (tDCS)
Trial Overview
The study tests if combining personalized brain stimulation (tDCS) with tailored physical therapy helps people with cerebellar damage. It looks at how practical and helpful this combined approach might be.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Lead Sponsor
Once Upon a Time Foundation
Collaborator
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