Individualized Neuro-Modulation Paired With Cerebellar Therapy

NCT07642856 | Recruiting DMC

• 1 other identifier: IRB00519286
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

non-invasive brain stimulation; rehabilitation; physical therapy

Outcome Measures

Primary Outcomes (2)

• Scale for the Assessment and Rating of Ataxia (SARA)

  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

  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.

Study Arms (2)

Active stimulation combined with therapy.

EXPERIMENTAL

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

Sham stimulation combined with therapy.

SHAM COMPARATOR

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

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.

Active stimulation combined with therapy.; Sham stimulation combined with therapy.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• Once Upon a Time Foundation: collaborator

Study Sites (1)

Motion Analysis Lab in the Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Cerebellar Ataxia; Cerebellar Diseases; Cerebellar Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Amy J Bastian, PhD, PT

  Motion Analysis Lab in the Kennedy Krieger Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Derek J Eversley, BS

CONTACT

443-923-2716; eversley@kennedykrieger.org

Anthony J Gonzalez, BS

CONTACT

443-923-2716; gonzalezan@kennedykrieger.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked in regards to receiving active or sham tDCS.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neuroscience

Model Details: All participants will receive exercise therapy. Some will receive active transcranial direct current stimulation and some will receive sham stimulation.

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): July 2, 2032
• Study Completion (Estimated): December 2, 2032
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

US (1)