TMS Treatment in Multiple System Atrophy With Fatigue

Study Overview
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Brief Summary
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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.

Official Title
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Study on the Effect and Mechanism of Transcranial Magnetic Stimulation in Multiple System Atrophy Patients With Fatigue

Conditions
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Transcranial Magnetic Stimulation, Multiple System Atrophy, Fatigue

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Contraindications for TMS (such as history of seizures, pregnant women, installation of pacemakers, metal inclusions in the body, intracranial hypertension, severe bleeding tendency, etc.) Patients who received TMS treatment for nearly half a year.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fatigue in MSA Arm one<br>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<br>* 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.<br>|
| Sham Comparator: fatigue in MSA Arm two<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 17-item Hamilton Depression Scale(HAMD-17) | To quantify changes of the severity of depression.The higher the score, the worse the depression. | Pre-treatment, post-treatment 0, 2, 4 weeks | 
| Changes in Hamilton Anxiety Scale(HAMA) | To quantify changes of the severity of anxiety.The higher the score, the worse the anxiety. | Pre-treatment, post-treatment 0, 2, 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMS,MSA,fMRI,Fatigue,functional, connectivity