Individualized Neuro-Modulation Paired With Cerebellar Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Therapy
BehavioralEach 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Active stimulation combined with therapy.Experimental treatment 1 intervention
Group B: Sham stimulation combined with therapy.Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.2
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).
Time frame
Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Lead sponsor
Once Upon a Time Foundation
Collaborator
Source ClinicalTrials.gov