The Treatment of Transcranial Alternating Current Stimulation(tACS)on Patients With Cerebellar Ataxia: A Randomized, Triple-blind, Parallel-controlled Study

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a longitudinal, triple-blind, randomized-controlled, prospective interventional study assessing patients with cerebellar ataxia, including spinocerebellar ataxia type 3 (SCA3) and multiple system atrophy-cerebellar type (MSA-C), to examine the efficacy, safety, and tolerability of transcranial alternating current stimulation (tACS) for up to 3 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• for SCA3

‣ Patients with detectable clinical signs and confirmed genetic diagnosis with SCA3

⁃ SCA3 patients aged 18 - 80 years

⁃ Patients or their family members have informed consent to the study and signed relevant documents

⁃ The pre-study ataxia Assessment Score (SARA) ranged from 3 to 30

• for MSA-C

‣ Aged 30-80 years

⁃ Diagnosed as clinically determined (Established)MSA-C or clinically Probable MSA-C according to the latest MSA diagnostic criteria

⁃ No more than 8 years after diagnosis of MSA-C

⁃ Able to walk independently or with assistance

⁃ Have a life expectancy of at least 3 years

⁃ Women of childbearing age with MSA need to use contraceptive measures

Locations
Other Locations
China
Department of Neurology, The First Affiliated Hospital Fujian Medical University
Fuzhou
Time Frame
Start Date: 2022-08-07
Completion Date: 2024-05-01
Participants
Target number of participants: 164
Treatments
Active_comparator: Real cerebellar tACS for Cerebellar Ataxia (Part Ⅰ: SCA3, Part Ⅱ: MSA-C)
Real cerebellar tACS, 70Hz, 2mA (peak to peak), 40min/day (10s ramp up and 10s ramp down), (10 sessions, 5 days/week for 2 weeks)
Sham_comparator: Sham cerebellar tACS for Cerebellar Ataxia (Part Ⅰ: SCA3, Part Ⅱ: MSA-C)
Device: Sham cerebellar tACS, 10Hz, 2mA (peak to peak) for 40s, and then no current 40min/day (10s ramp up and 10s ramp down), (10 sessions, 5 days/week for 2 weeks)
Sponsors
Leads: First Affiliated Hospital of Fujian Medical University

This content was sourced from clinicaltrials.gov