rTMS Improves Functions in Spinocerebellar Ataxia

NCT05973019 | Unknown DMC

• 1 other identifier: 230425
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Transcranial Magnetic Stimulation; Spinocerebellar Ataxias

Keywords

rTMS; SCA

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Concentration of Neurofilament

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

• Changes of Mini-mental state examination

  Baseline (T0)

Study Arms (1)

rTMS with 10 Hz

EXPERIMENTAL

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

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

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

rTMS with 10 Hz

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (2)

Changhua christian hospital

Changhua, 500, Taiwan

RECRUITING

Changhua christian hospital

Changhua, 500, Taiwan

RECRUITING

MeSH Terms

Conditions

Spinocerebellar Ataxias

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebellar Ataxia; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Sen Yung Liu, MD

  Changhua Christian Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sen Yung Liu, MD

CONTACT

88647238595; 88925@cch.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Model Details: All subjects receive 12 times rTMS intervention

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: September 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

TW (2)