Recruiting

tDCS with Rehabilitation

Sponsor:

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

Code:

NCT07642856

Conditions

Cerebellar Ataxia

Cerebellar Diseases

Cerebellar Stroke

Cerebellar Tumor

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Therapy

Study Details

Brief 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.

Conditions

Cerebellar Ataxia

Cerebellar Diseases

Cerebellar Stroke

Cerebellar Tumor

Study ID

NCT07642856

Start date

Jun 30, 2026

Status verified date

Jun, 2026

Completion date

Dec 2, 2032

Anticipated

Primary completion date

Jul 2, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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. ]
  • Patient-Reported Outcome Measure of Ataxia [ Time Frame: Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups. ]

Central Contacts and Locations

Central contacts

Derek J Eversley, BS

443-923-2716eversley@kennedykrieger.org

Anthony J Gonzalez, BS

443-923-2716gonzalezan@kennedykrieger.org

Locations

Motion Analysis Lab in the Kennedy Krieger Institute

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Anthony J Gonzalez, BS

443-923-2716gonzalezan@kennedykrieger.org

Principal Investigator:

Amy J Bastian, PhD, PT

More Information

Sponsor

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

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • non-invasive brain stimulation
  • rehabilitation
  • physical therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. on 2026-06-11.