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Recruiting NCT05625620

Cerebellar-spinal Transcranial Pulsed Current Stimulation (tPCS) for Treatment of Neurodegenerative Ataxia

Conditions: Cerebellar Ataxia

Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 15
Sponsor: Western University, Canada

Location: Canada

Summary

Neurodegenerative ataxia represents a group of disabling diseases. Patients mainly present with imbalance during walking, speech problem and difficulty in co-ordination during working with hands. No effective treatment is currently available for them. Currently, studies are going on the effectiveness of noninvasive brain stimulation (NIBS) in neurodegenerative diseases. It is a mode of brain stimulation technique where current is delivered into the brain by placing electrodes into their scalp. Transcranial pulsed current stimulation (tPCS) is a new modality of NIBS. . The clinical benefit observed after a single session of tPCS in 15 patients with neurodegenerative ataxia, suggest that prolonged stimulation could be even more effective. The investigator have planned to study the efficacy of long-term tPCS in these patients of neurodegenerative ataxia.Patients will be first examined clinically by the researcher along with the Scale for the Assessment and Rating of Ataxia (SARA) and Cerebellar Cognitive Affective Syndrome Scale (CCAS). Upper limb motor function, speech and Gait will be assessed according to the established protocol.After the screening visit and inclusion, all patients will be randomized into daily cerebello- spinal tPCS or sham stimulation.Anodal stimulation will be used for cerebellum and cathodal stimulation for the spinal stimulation. 20 min of non-invasive stimulation will be given via tPCS either real or sham stimulation. Patients will be trained and tolerability and ability to self-administer tPCS at home will be determined. Patients will continue tPCS at home 20 min daily for 2 weeks (7 days/week for 2 weeks). Assessments will be carried out 2 weeks after the first intervention (either real or sham tPCS).Then, patients will be reassessed at 1-month and 3-months follow-ups. After a washout period of 3 months since the last visit, each patient will receive the opposite treatment and undergo the same standardized assessment as in the first phase.

Eligibility Criteria

Inclusion Criteria:Patients diagnosed with neurodegenerative ataxia (clinically or by genetic study).Exclusion Criteria:Patients unable to walk even with support (wheelchair or bed bound patients for example)Other comorbidities deemed by the investigators to interfere with clinical, motor, gait or qEEG assessments.Patients with PacemakerPatients with metal implants in the head/neck regionSevere comorbidityIntake of illegal drugsPregnancyPatients unable to provide informed consentPatients unable to communicate in English.

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Source: ClinicalTrials.gov (NCT05625620). StuddyBuddy aggregates publicly available trial information.