Individualized Neuro-Modulation Paired With Cerebellar Therapy

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study ID
NCT07642856
Status
Recruiting
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Conditions

  • Cerebellar Ataxia
  • Cerebellar Diseases
  • Cerebellar Stroke
  • Cerebellar Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jul 2, 2032
Completion
Dec 2, 2032

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Motion Analysis Lab in the Kennedy Krieger InstituteBaltimoreMaryland21205
Anthony J Gonzalez, BS
[email protected]
443-923-2716
Amy J Bastian, PhD, PT (PRINCIPAL_INVESTIGATOR)

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By research site
Motion Analysis Lab in the Kennedy Krieger Institute· Baltimore, MD

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