Brain Stimulation to Improvement After Cerebellar Damage
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorGeorge Wittenberg
About this trial
The work will examine the mechanisms and potential therapeutic effects of transcranial magnetic stimulation on upper-limb sensorimotor function in individuals with cerebellar dysfunction, including those with damage due to stroke or autoimmune disease.
The study team will work toward a goal of non-invasive stimulation-based neuromodulatory interventions for cerebellar disorders using a closely integrated, clinically oriented cross-species approach. There will be a related study in nonhuman primates.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18-100 years old,
native English speakers,
medically stable to participate in the study.
presenting with a cerebellar disorder including cerebellar stroke
Disqualifiers
are unable to give consent,
have contractures, orthopedic problems, or other impairments that would interfere with the use of the robot or limit the range of joint motion in the potential study arm,
presence of medical condition or implant that prevents safe administration of stimulation (history of seizures, and/or taking any of the following medications: lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), topiramate (Topamax), phenytoin (Dilantin), arbamazepine (Tegretol), valproic acid (Depakote), or phenobarbital (Barbita, Luminal, Solfoton).
have any factor that precludes participation in a magnetic resonance imaging (MRI) session (e.g. ferrous metal in the body), or
Trial design
Design model
Single group
Treatments tested in this trial
Transcranial Magnetic Stimulation
DeviceStimulation of continuous theta burst stimulation at 80% of resting motor threshold over the region targeted for modulation after behavioral testing, with resting of behavior afterwards.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Parietal Brain StimulationExperimental treatment 1 intervention
Group B: Cerebellar brain stimulationExperimental treatment 1 intervention
Group C: Parietal Midline Brain stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Motor Assessments with KINARM Robot
In the arm position matching task, the robot will move one arm to a target location, and participants will match the perceived position with the opposite arm (\~50 trials per assessment, \~10 minutes). In the alternating reaching task, participants will make rapid alternating reaches between targets while keeping the movement within a visually defined channel or bounded path (\~80 reaches per assessment, \~10 minutes). In the clamped feedback reaching task, participants will complete brief sequences of center-out reaches designed to measure single-trial adaptation. Each sequence will include no-feedback reaches surrounding a trial with experimentally manipulated cursor feedback. During clamped-feedback trials, the cursor will move along a fixed path relative to the target, independent of the participant's actual hand direction. Adaptation will be estimated from changes in reach direction on subsequent no-feedback reaches (\~120 total trials per assessment, \~15 minutes).
Time frame
From enrollment to the end of treatment at 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
George Wittenberg
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov
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