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Spinocerebellar Ataxia Type 3NCT05557786

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

A study testing Transcranial Alternating Current Stimulation in people with Spinocerebellar Ataxia Type 3 and Multiple System Atrophy-cerebellar Type, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Transcranial Alternating Current Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
164 participants
Where
1 siteChina
Study dates
7 Aug 2022to 1 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Neurology, The First Affiliated Hospital Fujian Medical University

    Fuzhou, Fujian, 350005

Other trials in China

About this study

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

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.

Read the detailed description

Transcranial alternating current stimulation (tACS) is a relatively recent method that noninvasively modulates brain oscillations, and can effectively stimulate deep brain regions, affect brain rhythm, increase neural plasticity, change neurotransmitter levels, and improve brain function. It is a comfortable, safe, effective, non-invasive, and easy-to-operate method, which means it has development potential in relevant medical fields. It has been approved by the FDA for clinically treating neuropsychiatric diseases.

This is a prospective, longitudinal, triple-blind, randomized-controlled, interventional study designed to evaluate the efficacy, safety, and tolerability of tACS in patients of SCA3 and MSA-C in China. Based on typical guidelines, we will use the tACS paradigm (bilateral mandible as a place for active electrode stimulation electrode, and the inion for the return electrode). This study has two parts. The patients studied in the Part Ⅰ are SCA3. The patients studied in the Part Ⅱ are MSA-C. Every part of study, subjects will be randomized into two groups, one receiving a 10-day (5 days/week for 2 weeks) treatment with real cerebellar tACS (CB-tACS) and the other receiving a sham stimulation. The patient's motor function, cognitive function, sleep, mental state, plantar pressure, and magnetic resonance imaging will be assessed before and after the intervention.

There will be a total of 4 visits. All patients receiving tACS will be visited face to face at baseline, day 1, day 30, and day 90 after the treatment begins.

Being tested
Transcranial Alternating Current Stimulation
Keywords
SCA3, MSA-C, tACS, Brain oscillations, effectiveness
Medical subject headings
Machado-Joseph Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Alternating Current StimulationDevice

    Cerebellar Transcranial Alternating Current Stimulation（tACS）

Study groups in NCT05557786
Study groupRoleWhat they receive
Real cerebellar tACS for Cerebellar Ataxia (Part Ⅰ: SCA3, Part Ⅱ: MSA-C)Active comparatorReal cerebellar tACS, 70Hz, 2mA (peak to peak), 40min/day (10s ramp up and 10s ramp down), (10 sessions, 5 days/week for 2 weeks)
Receives: Device: Transcranial Alternating Current Stimulation
Sham cerebellar tACS for Cerebellar Ataxia (Part Ⅰ: SCA3, Part Ⅱ: MSA-C)Sham comparatorDevice: 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)
Receives: Device: Transcranial Alternating Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline - 2 weeks

  2. 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.

    Measured: Baseline - 2 weeks

Secondary outcomes (8)

  1. For Part Ⅰ SCA3 -2

    To compare the proportion of patients with SARA improvement (decrease) of at least 1.5 from baseline after 1 month and 3 months, assessing changes in the SARA Score.

    Measured: 1 month - 3 months

  2. For Part Ⅰ SCA3 -3

    Changes in the Scale for the SARA improvement (decrease) from baseline to 2 weeks, 1 month and 3 months.

    Measured: Baseline - 2 weeks - 1 month - 3 months

  3. For Part Ⅰ SCA3 -4

    Changes in the Scale for the 5 Level EQ-5D (EQ-5D-5L) improvement (decrease) from baseline to 2 weeks, 1 month and 3 months.

    The EQ-5D-5L is a standard measure of health-related quality of life. EQ-5D-5L consists of two components: a health state profile and a visual analog scale (VAS). EQ-5D health state profile comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where a higher score indicates a better health state. The VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine." Higher scores of EQ-VAS indicate better health.

    Measured: Baseline - 2 weeks - 1 month - 3 months

  4. For Part Ⅱ MSA-C -2

    Changes in the Scale for the UMSARS improvement (decrease) from baseline to 1 month and 3 months.

    Measured: 1 month - 3 months

  5. For Part Ⅱ MSA-C -3

    Changes in the Scale for the UMSARS II improvement (decrease) from baseline to 2 weeks, 1 month and 3 months.

    Measured: Baseline - 2 weeks - 1 month - 3 months

  6. For Part Ⅱ MSA-C -4

    Changes in the Scale for the SARA improvement (decrease) from baseline to 2 weeks, 1 month and 3 months.

    Measured: Baseline - 2 weeks - 1 month - 3 months

  7. For Part Ⅱ MSA-C -5

    Changes in the Scale for the Autonomic Scale for Outcomes in Parkinson's Disease (SCOPA-AUT) Score improvement (decrease) from baseline to 2 weeks, 1 month and 3 months.

    Measured: Baseline - 2 weeks - 1 month - 3 months

  8. For Part Ⅱ MSA-C -6

    Changes in the Scale for the Multiple System Atrophy Quality of Life (MSA-QoL) Score improvement (decrease) from baseline to 2 weeks, 1 month and 3 months.

    The score of other sub-dimension of the MSA Quality of Life scale. The MSA-QoL questionnaire is composed of three different subscales: motor (14 items), non-motor (12 items), and emotional/social (14 items). The response options for each question range from 0 (no problem) to 4 (extreme problem), with higher total scores reflecting more impaired quality of life. The MSA-QoL also includes a visual analog scale (VAS) of how satisfied patients feel (range 0-100, with lower scores indicating a lower quality of life).

    Measured: Baseline - 2 weeks - 1 month - 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2022
  2. Study start7 Aug 2022
  3. Primary completion9 Mar 2024
  4. Study completion1 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05557786
Sponsor's protocol ID
MRCTA, ECFAH of FMU[2022]399
Status last verified
Jul 2024
First submitted
24 Sep 2022
Last updated
12 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40532663

  • 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.

    PubMed 37179566

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Alternating Current Stimulation in people with Spinocerebellar Ataxia Type 3 and Multiple System Atrophy-cerebellar Type, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

For Part Ⅰ (SCA3) -1 (time frame: Baseline - 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05557786, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.

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