TMS Treatment in Multiple System Atrophy With Fatigue

NCT04313530 | Unknown DMC

• 1 other identifier: 1225435380@qq.com
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Transcranial magnetic stimulation (TMS) is a procedure that has been shown to improve fatigue in chronic sufferers. It uses a plastic covered coil that sends a magnetic pulse through the skull into the brain and by targeting particular areas in the brain it can be used to help modulate the perception of fatigue. The study intends to use this technique to treat such a disabling symptom in patients who suffer from Multiple System Atrophy (MSA). Initially the aim is to study this technique in 22 MSA patients who are suffering from fatigue . These patients would require an resting-state funtional MRI before and after the stimulation. The stimulation would be performed ten sessions and the patients would be assessed by a clinician using well recognized clinical tools. It is anticipated that there will be a meaningful improvement in fatigue. It is also anticipated that TMS is a safety technique to use in MSA patients . Our findings will revealed that fatigue may be associated with an altered default mode network and sensorimotor network connectivity in MSA patients. We hypothesize that these divergent motor and cognitive networks connectivity changes and their adaptive or maladaptive functional outcome may play a prominent role in the pathophysiology of fatigue in MSA.

Conditions

Transcranial Magnetic Stimulation; Multiple System Atrophy; Fatigue

Keywords

TMS,MSA,fMRI,Fatigue,functional, connectivity

Outcome Measures

Primary Outcomes (1)

• Changes in Fatigue Severity Scale-9 (FSS-9)

  To quantify changes of the severity of fatigue.The higher the score, the worse the fatigue.

  Pre-treatment, post-treatment 0, 2, 4 weeks

Secondary Outcomes (2)

• Changes in 17-item Hamilton Depression Scale(HAMD-17)

  Pre-treatment, post-treatment 0, 2, 4 weeks

• Changes in Hamilton Anxiety Scale(HAMA)

  Pre-treatment, post-treatment 0, 2, 4 weeks

Study Arms (2)

fatigue in MSA Arm one

EXPERIMENTAL

This arm will receive a total 10 sessions of TMS stimulation in two weeks. Pre and post intervention scales will be performed on week one, week 2 and week 4.

Device: Repetitive Transcranial Magnetic Stimulation

fatigue in MSA Arm two

SHAM COMPARATOR

This arm will receive a total 10 sessions of sham-TMS stimulation in two weeks. Pre and post intervention scales will be performed on week one, week 2 and week 4.

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

Transcranial magnetic stimulation (TMS) is a non-invasive method that uses electromagnetic induction to produce electric currents in the cortex that are strong enough to depolarise neurons sufficiently to trigger action potentials. It is an outpatient based procedure that when used in conjunction with a neuro-navigation system, specific cortical areas can be targeted for greater accuracy and efficacy. In clinical studies, TMS is delivered as trains of pulses (repetitive TMS, rTMS) to prolong its effects. While the exact mechanism of TMS treatment fatigue is unknown, it is thought to regulate the activity of the complex cortical and subcortical networks connectivity changes involved in the processing of fatigue signals.

fatigue in MSA Arm one; fatigue in MSA Arm two

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Multiple system atrophy diagnosed as "possible" or "probable" according to the 2008 MDS clinical diagnostic criteria;
• Age ≥30Aged ≤ 75years old;
• right handedness
• MMSE\>24
• the dosage and species of anti-parkinson drug is maintained during the treatment;
• The patient or his/her legal guardian agreed to participate in the trial and signed the informed consent.Ability to follow research plans and visit plans.
• FSS≥4

You may not qualify if:

• Serious medical and mental illness;
• History of stroke, intracranial tumor and other central nervous system;
• Patients with suicidal tendencies and psychotic symptoms.
• MRI for contraindications, such as metal implants, claustrophobia, etc
• Patients who received TMS treatment for nearly half a year.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

The Neurology Department of Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Multiple System Atrophy; Fatigue

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Biao Chen, MD,PHD

  Xuanwu Hospital of Capital Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: October 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: May 1, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

CN (1)