ClinicalTrials.gg
RecruitingNCT05973019Updated Oct 18, 2023

rTMS Improves Functions in Spinocerebellar Ataxia

An interventional study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Transcranial Magnetic Stimulation and Spinocerebellar Ataxias, sponsored by Changhua Christian Hospital. Recruiting at 2 sites in Taiwan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-18.

Sponsored by Changhua Christian Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 2 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Spinocerebellar Ataxias with a site in Taiwan — 4 open to participants now, 5 under way, none of them phase 3. Spinocerebellar Ataxias · Taiwan.

Planned enrollment
10th of 10
10 · median 40
Started
2023
the only one that year
No phase
7 of 10
4 open now
Registered
6th of 10
by date
Lead sponsor
2 of 10
Changhua Christian Hospital

Among the 10 studies in Spinocerebellar Ataxias with a site in Taiwan, this one is the 10th largest by planned enrollment, is the only one that started in 2023, is one of 7 with no phase, and was the 6th registered.

Spinocerebellar Ataxias

95 studies on the registry are indexed under Spinocerebellar Ataxias; 25 are open to participants now.

Browse Spinocerebellar Ataxias studies →

Open to participants now

4 of the 10 studies in Spinocerebellar Ataxias with a site in Taiwan are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →

Who these studies take

Of the 16 Spinocerebellar Ataxias studies recruiting now, 8 (50%) set no upper age limit and 3 (19%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study summary

Spinocerebellar ataxia (SCA) is a group of inherited brain disorders. SCA often result in poor limb coordination. This study aims to discover the effects of repeated transcranial magnetic stimulation (rTMS) on balance \& gait in SCA. The hypothesis of this study is that rTMS might improve SCA limb functional performance.

Read the detailed description

rTMS has been shown that improves walking speed and balance performance, however, the optimal treatment protocols have not been approved. Past studies used different frequencies 1 Hz, 5 Hz and 10 Hz to improve functional performance. The results might be affected by the types of SCA. In this study, we will focus on the SCA type 3 to assess the effects on high frequency (10 Hz) of rTMS intervention.

03

Conditions studied

  • Transcranial Magnetic Stimulation
  • Spinocerebellar Ataxias

Keywords

  • rTMS
  • SCA
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • SCA type 3
  • independently walk with/without an assistive device
  • SARA greater than 3

Exclusion criteria

Exclusion Criteria:

  • Epilepsy history
  • Unstable blood pressure
  • Brain Trauma
  • Alcoholism, drug abuse, antipsychotics drug use
  • Metallic hardware (e.g. - cochlear implants, brain stimulators or electrodes, aneurysm clips) anywhere in head.
  • Dementia, depression
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    rTMS with 10 Hz

    6 times/per week for 2 weeks, total 12 times rTMS.

    Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

  • DeviceRepetitive Transcranial Magnetic Stimulation (rTMS)

    6 times/per week for 2 weeks, total 12 times rTMS with 10 Hz.

06

What researchers measure

Primary outcomes

  1. Changes of International Cooperative Ataxia Rating Scale

    International Cooperative Ataxia Rating Scale (ICARS): quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Disorders rated as subscales within the ICARS are: Postural and gait disturbances, Limb Ataxia, Dysarthria, and Oculomotor disorders.It translates the symptomatology of cerebellar ataxia into a scoring system out of 100.

    Time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),

  2. Changes of SARA

    Scale for the Assessment and Rating of Ataxia (SARA): a tool for assessing ataxia. It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).

    Time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),

  3. Changes of Berg Balance Scale

    Berg Balance Scale (BBS): a widely used assessment to determine a person's balance abilities. The test contains 14 simple tasks, scoring ranges from 0 to 56. The lower your score, the more at risk you are for losing your balance. The entire process takes about 20 minutes to complete.

    Time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),

  4. Changes of Timed up and go

    Timed up and go (TUG): Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.

    Time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),

  5. Changes of Center of pressure trajectory

    Center of pressure (COP): he trajectory of the COP, commonly known as a stabilogram, during static balance is frequently used to measure postural control. When standing still on a force platform, the COP is thought to be an indicator of the motor mechanisms involved in maintaining balance with opened-eyes or closed-eyes. Two trials for each condition were performed within 5 minutes.

    Time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),

  6. Changes of Kinematic of Gait

    The joint angles of hip, knee, ankle are collected during walking in a 10 meters walkway.

    Time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),

  7. Changes of Electromyography of Gait

    A wireless surface Electromyography (EMG) is used to collect lower extremities muscle activation signals during walking in a walkway.

    Time frame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),

Secondary outcomes

  1. Concentration of Neurofilament

    neurofilament proteins is the biomarkers of axonal damage in diseases affecting the central nervous system

    Time frame: Baseline (T0), 12 days after first rTMS intervention (T2)

  2. Changes of Mini-mental state examination

    The mini-mental state examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment. In this study, it is used to rule out subjects who might have dementia.

    Time frame: Baseline (T0)

07

Study locations

2 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Jun 2024, 9 months after the start.

Of 28 interventional studies with no phase under Spinocerebellar Ataxias, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2023
First posted
Aug 2, 2023
StartActual
Sep 1, 2023
Primary completionEst.
Jun 30, 2024
CompletionEst.
Aug 1, 2024
Last update
Oct 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05973019
Lead sponsor
Changhua Christian Hospital
Responsible party
Sen-yung Liu (Chief Medical Officer, Changhua Christian Hospital) — Principal investigator
First posted
Aug 2, 2023
Start date
Sep 1, 2023
Primary completion
Jun 30, 2024 (estimated)
Completion
Aug 1, 2024 (estimated)
Last update
Oct 18, 2023

Study contacts

Sen Yung Liu, MD
Contact
88925@cch.org.tw
88647238595 ext. 7427
Sen Yung Liu, MD
principal investigator · Changhua Christian Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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