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.
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
- Conditions the study is for
- Spinocerebellar Ataxia Type 3, Multiple System Atrophy-cerebellar Type
- 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
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
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- 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
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- 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
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Device: Transcranial Alternating Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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
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
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
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
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
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.
- First posted28 Sep 2022
- Study start7 Aug 2022
- Primary completion9 Mar 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinocerebellar Ataxia Type 3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University
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 40532663Liu 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