Clinical trial NCT04313530: TMS Treatment in Multiple System Atrophy With Fatigue
Official title: Study on the Effect and Mechanism of Transcranial Magnetic Stimulation in Multiple System Atrophy Patients With Fatigue
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Multiple System Atrophy
Fatigue
Keywords: TMS,MSA,fMRI,Fatigue,functional, connectivity
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Fatigue Severity Scale-9 (FSS-9)
timeFrame: Pre-treatment, post-treatment 0, 2, 4 weeks
Secondary outcomes:
measure: Changes in 17-item Hamilton Depression Scale(HAMD-17)
timeFrame: Pre-treatment, post-treatment 0, 2, 4 weeks
measure: Changes in Hamilton Anxiety Scale(HAMA)
timeFrame: Pre-treatment, post-treatment 0, 2, 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Neurology Department of Xuanwu Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital of Capital Medical University
name: Biao Chen, MD,PHD
role: STUDY_CHAIR
References: