Treatment of Transcranial Alternating Current Stimulation（tACS）on Cerebellar Ataxia

NCT05557786 | Completed DMC

• 1 other identifier: MRCTA, ECFAH of FMU[2022]399
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinocerebellar Ataxia Type 3; Multiple System Atrophy-cerebellar Type

Keywords

SCA3; MSA-C; tACS; Brain oscillations; effectiveness

Outcome Measures

Primary Outcomes (2)

• For Part Ⅰ (SCA3) -1

  To compare the proportion of patients with SARA improvement (decrease) of at least 1.5 from baseline after 2 weeks, assessing changes in the Assessment and Rating of Ataxia (SARA) Score.

  Baseline - 2 weeks

• For Part Ⅱ (MSA-C) -1

  Changes of Clinical Evaluation for (Unified Multiple System Atrophy Rating Scale) UMSARS improvement (decrease) from baseline to 2 weeks. UMSARS I: This is an assessment of daily life activities via 12 items scale used to assess language, writing, autonomy, walking, and the presence of possible urinary, sexual, or intestinal disorders. (0=no disorder, 48=severe) UMSARS II: Motor examination based on 14 items that evaluate particular facial expression, oculomotricity, oral expression, tremors, or walking. 0= no disorder, 56=severe disorders. UMSARS III: Blood pressure and heart rate measurements in lying and standing positions for 10 min every minute. UMSARS IV: Assessment of the disability from 1 to 5; 1 = completely independent; 5 = totally dependent.

  Baseline - 2 weeks

Secondary Outcomes (8)

• For Part Ⅰ SCA3 -2

  1 month - 3 months

• For Part Ⅰ SCA3 -3

  Baseline - 2 weeks - 1 month - 3 months

• For Part Ⅰ SCA3 -4

  Baseline - 2 weeks - 1 month - 3 months

• For Part Ⅱ MSA-C -2

  1 month - 3 months

• For Part Ⅱ MSA-C -3

  Baseline - 2 weeks - 1 month - 3 months

Other Outcomes (1)

• For SCA3 and MSA-C

  Baseline-2 weeks - 1 month - 3 months

Study Arms (2)

Real cerebellar tACS for Cerebellar Ataxia (Part Ⅰ: SCA3, Part Ⅱ: MSA-C)

ACTIVE COMPARATOR

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)

Device: Transcranial Alternating Current Stimulation

Sham cerebellar tACS for Cerebellar Ataxia (Part Ⅰ: SCA3, Part Ⅱ: MSA-C)

SHAM COMPARATOR

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)

Device: Transcranial Alternating Current Stimulation

Interventions

Transcranial Alternating Current Stimulation DEVICE

Cerebellar Transcranial Alternating Current Stimulation（tACS）

Real cerebellar tACS for Cerebellar Ataxia (Part Ⅰ: SCA3, Part Ⅱ: MSA-C); Sham cerebellar tACS for Cerebellar Ataxia (Part Ⅰ: SCA3, Part Ⅱ: MSA-C)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who have concomitant epilepsy.
• Patients with a serious cognitive disorder, behavioral disorder, or mental illness
• Patients with a history of seizures, stroke, encephalitis, or other degenerative neurological diseases
• Patients with a serious medical disease
• Patients who concomitantly suffer from severe renal impairment, convulsions, stomach ulcers, or moderate or more severe liver disease
• Patients with uncontrolled high blood pressure or diabetes
• History of head injury or neurosurgical interventions.
• History of any metal in the head (outside the mouth).
• Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line), or any medical pumps.
• Patients who have taken other investigational products within 4 weeks before being enrolled in this clinical trial, or patients who are pregnant or breastfeeding.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

Department of Neurology, The First Affiliated Hospital Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Related Publications (2)

• Chen X, Liu X, Lin W, Zhang L, Cheng X, Huang Z, Zhang W, Zeng H, Lian Y, Zhang Y, Li M, Chen N, Huang S, Wang Z, Wang X, Liu Z, Yuan R, Chen X, Ye Z, Cheng B, Zhang Y, Chen Q, Wang D, Ni J, Wang N, Fu Y, Gan S; OSCCAR Investigators. Transcranial alternating current stimulation for treating spinocerebellar ataxia type 3: A randomized controlled trial. Cell Rep Med. 2025 Jun 17;6(6):102162. doi: 10.1016/j.xcrm.2025.102162.

  PMID: 40532663 DERIVED

• Liu X, Lin W, Zhang L, Zhang WL, Cheng XP, Lian YH, Li MC, Wang SZ, Chen XY, Gan SR. Effects of cerebellar transcranial alternating current stimulation in cerebellar ataxia: study protocol for a randomised controlled trial. Front Neurosci. 2023 Apr 27;17:1180454. doi: 10.3389/fnins.2023.1180454. eCollection 2023.

  PMID: 37179566 DERIVED

MeSH Terms

Conditions

Machado-Joseph Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Spinocerebellar Ataxias; Cerebellar Ataxia; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 24, 2022
• First Posted: September 28, 2022
• Study Start: August 7, 2022
• Primary Completion: March 9, 2024
• Study Completion: May 1, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

CN (1)