TMS Treatment in Multiple System Atrophy With Fatigue

Not Applicable

• Conditions: Transcranial Magnetic Stimulation; Multiple System Atrophy; Fatigue
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT04313530
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-18
• Primary Completion: 2022-01-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-26
• Last Update Posted: 2022-04-06
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Patients with Multiple system atrophy diagnosed as "possible" or "probable" according to the 2008 MDS clinical diagnostic criteria;
2. Age ≥30Aged ≤ 75years old;
3. right handedness
4. MMSE>24
5. the dosage and species of anti-parkinson drug is maintained during the treatment;
6. 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.
7. FSS≥4

Exclusion Criteria

1. Serious medical and mental illness;
2. History of stroke, intracranial tumor and other central nervous system;
3. Patients with suicidal tendencies and psychotic symptoms.
4. MRI for contraindications, such as metal implants, claustrophobia, etc
5. Contraindications for TMS (such as history of seizures, pregnant women, installation of pacemakers, metal inclusions in the body, intracranial hypertension, severe bleeding tendency, etc.)
6. Patients who received TMS treatment for nearly half a year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fatigue in MSA Arm two	Repetitive Transcranial Magnetic Stimulation	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.
fatigue in MSA Arm one	Repetitive Transcranial Magnetic Stimulation	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.

Primary Outcome Measures

Name	Time	Method
Changes in Fatigue Severity Scale-9 (FSS-9)	Pre-treatment, post-treatment 0, 2, 4 weeks	To quantify changes of the severity of fatigue.The higher the score, the worse the fatigue.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Neurology Department of Xuanwu Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China