Clinical trial NCT05973019: rTMS Improves Functions in Spinocerebellar Ataxia
Official title: Repetitive Transcranial Magnetic Stimulation Improves Functional Performance in Spinocerebellar Ataxia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Spinocerebellar Ataxias
Keywords: rTMS
SCA
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects receive 12 times rTMS intervention
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Changes of International Cooperative Ataxia Rating Scale
timeFrame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
measure: Changes of SARA
timeFrame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
measure: Changes of Berg Balance Scale
timeFrame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
measure: Changes of Timed up and go
timeFrame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
measure: Changes of Center of pressure trajectory
timeFrame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
measure: Changes of Kinematic of Gait
timeFrame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
measure: Changes of Electromyography of Gait
timeFrame: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Secondary outcomes:
measure: Concentration of Neurofilament
timeFrame: Baseline (T0), 12 days after first rTMS intervention (T2)
measure: Changes of Mini-mental state examination
timeFrame: Baseline (T0)
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua christian hospital
city: Changhua
country: Taiwan
facility: Changhua christian hospital
Study officials:
affiliation: Changhua Christian Hospital
name: Sen Yung Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: