rTMS Improves Functions in Spinocerebellar Ataxia

Transcranial Magnetic Stimulation Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation Improves Functional Performance in Spinocerebellar Ataxia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05973019
• Other study ID #: 230425
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: October 2023
• Source: Changhua Christian Hospital
• Contact: Sen Yung Liu, MD
• Phone: 88647238595
• Email: 88925[@]cch.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia
• Spinocerebellar Ataxias
• Spinocerebellar Degenerations
• Transcranial Magnetic Stimulation

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation (rTMS)
6 times/per week for 2 weeks, total 12 times rTMS with 10 Hz.

Locations

Country	Name	City	State
Taiwan	Changhua christian hospital	Changhua
Taiwan	Changhua christian hospital	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Primary	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).	Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Primary	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.	Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Primary	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.	Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Primary	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.	Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Primary	Changes of Kinematic of Gait	The joint angles of hip, knee, ankle are collected during walking in a 10 meters walkway.	Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Primary	Changes of Electromyography of Gait	A wireless surface Electromyography (EMG) is used to collect lower extremities muscle activation signals during walking in a walkway.	Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Secondary	Concentration of Neurofilament	neurofilament proteins is the biomarkers of axonal damage in diseases affecting the central nervous system	Baseline (T0), 12 days after first rTMS intervention (T2)
Secondary	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.	Baseline (T0)