Speech-motor behavioral testing

Not currently recruiting at 2 trial locations
Cf
AF
Overseen ByAnne Findlay
Age: 18+
Sex: Any
Travel: May Be Covered
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the cerebellum, a part of the brain, contributes to speech learning and correction in individuals with cerebellar ataxia, a condition causing coordination problems, and in healthy individuals. Participants will engage in speaking tasks while undergoing MRI (Magnetic Resonance Imaging) scans to examine brain activity. Some may also experience TMS (Transcranial Magnetic Stimulation), a technique that briefly influences brain function. Those with cerebellar ataxia and healthy volunteers with normal speech and hearing and no other neurological issues may qualify. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on brain function and speech.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are a healthy volunteer, certain medications might be a concern for TMS participation. It's best to discuss your specific medications with the study team.

What prior data suggests that TMS and MRI are safe for studying cerebellar ataxia?

Research has shown that transcranial magnetic stimulation (TMS) is generally well-tolerated by people with cerebellar ataxia. TMS is a non-invasive method that uses magnetic fields to stimulate the brain. Most participants in a study experienced only mild side effects, such as slight headaches or discomfort at the stimulation site, which usually resolved quickly. Another review supports these findings, noting that serious side effects are rare.

Magnetic resonance imaging (MRI) is a commonly used imaging technique considered safe. It uses strong magnets and radio waves to create detailed pictures of the brain. MRI does not involve radiation, and most people tolerate it well. Some might feel a bit uncomfortable or claustrophobic inside the MRI machine, but this can be managed.

Overall, both TMS and MRI have been shown to be safe for humans, with only minor and temporary side effects reported in studies.12345

Why are researchers excited about this trial?

Researchers are excited about using TMS (Transcranial Magnetic Stimulation) and MRI (Magnetic Resonance Imaging) for cerebellar ataxia because these methods offer new ways to understand and potentially manage this condition. Unlike standard treatments, which often focus on symptom management through medication and physical therapy, TMS provides a non-invasive way to stimulate brain areas that might improve motor functions. MRI helps researchers to visualize changes in brain activity and structure, offering insights into how cerebellar ataxia affects the brain. Together, these techniques could lead to breakthroughs in how we understand and treat cerebellar ataxia, offering hope for more effective interventions in the future.

What evidence suggests that this trial's approaches could be effective for cerebellar ataxia?

Research has shown that transcranial magnetic stimulation (TMS) can help manage cerebellar ataxia, a movement disorder. In this trial, some participants will receive TMS. Specifically, studies have found that patients who received TMS showed noticeable improvements in their symptoms. This non-invasive method stimulates the brain to enhance coordination. Many patients have experienced better movement, suggesting TMS could be a promising treatment option. Overall, TMS is considered safe and is gaining interest due to its positive effects on ataxia.13467

Who Is on the Research Team?

RI

Richard Ivry, Ph.D.

Principal Investigator

University of California, Berkeley

BP

Ben Parrell, Ph.D.

Principal Investigator

University of Wisconsin, Madison

JF

John F. Houde, Ph.D.

Principal Investigator

University of California, San Francisco

SS

Srikantan S. Nagarajan, Ph.D.

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for people with cerebellar ataxia who have normal hearing and speak American English, or healthy individuals without physical/neurological issues. Participants must not have seizures, metal implants, heart disease, be pregnant, use hearing aids, or suffer from psychiatric illnesses unrelated to cerebellar damage.

Inclusion Criteria

For some studies, primary language of American English may be required
You have a condition called cerebellar ataxia that affects your balance and coordination and you have no hearing problems, OR you are a healthy person with no history of physical or neurological problems and have normal speech, hearing, and reading abilities.

Exclusion Criteria

Ongoing seizures that are not well controlled despite medication
Any contraindications to participating in a TMS study including the following: epilepsy, use of certain medications, heart disease, and pregnancy; scalp wounds or infections; any other contraindication discovered during screening procedures
Any condition that would prevent the subject from giving voluntary informed consent
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Behavioral Studies

Participants perform speaking tasks while their voice is played back over earphones, and other speaking tasks are conducted.

4-6 weeks
Multiple visits (in-person)

MRI Studies

MRI is acquired to analyze brain function and anatomy related to speech and the cerebellum.

1-2 weeks
1-2 visits (in-person)

TMS Studies

In healthy controls, TMS is performed to temporarily disrupt the cerebellum during speaking tasks.

1-2 weeks
1-2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main study activities.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MRI
  • Speech-motor behavioral testing
  • TMS
Trial Overview The study examines the cerebellum's role in speech by using behavioral tests where participants talk into a mic with voice feedback. MRI scans analyze brain function and anatomy related to speech. In healthy subjects only, TMS disrupts cerebellum activity during speaking tasks.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Patients with cerebellar ataxia (CA)Experimental Treatment2 Interventions
Group II: Additional healthy volunteersExperimental Treatment3 Interventions
Group III: Matched controlsActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

University of Wisconsin, Madison

Collaborator

Trials
1,249
Recruited
3,255,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

University of California, Berkeley

Collaborator

Trials
193
Recruited
716,000+

Published Research Related to This Trial

A review of 84 single pulse and paired-pulse TMS studies with 1091 Parkinson's disease patients, and 77 repetitive TMS studies with 1137 patients, found a very low risk of adverse events, with no seizures reported.
The overall risk of adverse events from rTMS was 0.040 per patient, with common side effects being mild and transient, such as headaches and scalp pain, indicating that TMS is generally safe for Parkinson's patients.
Safety of transcranial magnetic stimulation in Parkinson's disease: a review of the literature.Vonloh, M., Chen, R., Kluger, B.[2021]

Citations

Repetitive transcranial magnetic stimulation for cerebellar ataxiaRepetitive transcranial magnetic stimulation, a non-invasive brain stimulation technique, can manage cerebellar ataxia (CA) by suppressing cerebral cortical ...
Effects of transcranial magnetic stimulation on cerebellar ...The effects of transcranial magnetic stimulation in improving cerebellar ataxia in the affected patients are significant.
Effects of cerebellar repetitive transcranial magnetic ...Additionally, a study involving six stroke patients treated with ipsilateral cerebellar iTBS found improvements in ataxia symptoms (Bonnì et al.
The efficacy of repetitive transcranial magnetic stimulationThe rTMS is a safe, noninvasive technique for brain stimulation that has attracted growing interest as a treatment for ataxia due to its capacity to promote ...
Transcranial Magnetic Stimulation in Spino-Cerebellar AtaxiaThe investigators anticipate that patients receiving the real intervention will show a functional gain. Detailed Description. Spinocerebellar Ataxia (SCA) ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36604400/
a Systematic Review and Meta-analysisEfficacy and Safety of Repetitive Transcranial Magnetic Stimulation in Cerebellar Ataxia: a Systematic Review and Meta-analysis. Cerebellum.
Feasibility of repetitive transcranial magnetic stimulation on ...Efficacy and safety of repetitive transcranial magnetic stimulation in spinocerebellar Ataxia type 3: a systematic review and meta-analysis ...
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