rTMS Improves Functions in Spinocerebellar Ataxia

Repetitive Transcranial Magnetic Stimulation Improves Functional Performance in Spinocerebellar Ataxia

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.

Study Overview

• Status: Recruiting
• Conditions: Transcranial Magnetic Stimulation; Spinocerebellar Ataxias
• Intervention / Treatment: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sen Yung Liu, MD; Phone Number: 7427 88647238595; Email: 88925@cch.org.tw

Study Locations

• Taiwan
  • Changhua, Taiwan, 500
    • Recruiting
    • Changhua Christian Hospital
    • Contact: Sen Yung Liu, MD; Phone Number: 7022 88647238595; Email: 88925@cch.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rTMS with 10 Hz; 6 times/per week for 2 weeks, total 12 times rTMS.	Device: Repetitive Transcranial Magnetic Stimulation (rTMS); 6 times/per week for 2 weeks, total 12 times rTMS with 10 Hz.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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),
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),
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),
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),
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),
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),
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Changhua Christian Hospital
• Investigators: Principal Investigator: Sen Yung Liu, MD, Changhua Christian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: rTMS; SCA
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Neurodegenerative Diseases; Dyskinesias; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Cerebellar Diseases; Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations
• Other Study ID Numbers: 230425

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No