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TMS Treatment in Multiple System Atrophy With Fatigue (TMSMSAF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04313530
Recruitment Status : Enrolling by invitation
First Posted : March 18, 2020
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
Piu Chan, Xuanwu Hospital, Beijing

Study Description
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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.


Condition or disease Intervention/treatment Phase
Transcranial Magnetic Stimulation Multiple System Atrophy Fatigue Device: Repetitive Transcranial Magnetic Stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study on the Effect and Mechanism of Transcranial Magnetic Stimulation in Multiple System Atrophy Patients With Fatigue
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : January 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arms and Interventions
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Arm Intervention/treatment
Experimental: fatigue in MSA Arm one
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
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.
Sham Comparator: fatigue in MSA Arm two
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Fatigue Severity Scale-9 (FSS-9) [ Time Frame: 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 :
  1. Changes in 17-item Hamilton Depression Scale(HAMD-17) [ Time Frame: Pre-treatment, post-treatment 0, 2, 4 weeks ]
    To quantify changes of the severity of depression.The higher the score, the worse the depression.

  2. Changes in Hamilton Anxiety Scale(HAMA) [ Time Frame: Pre-treatment, post-treatment 0, 2, 4 weeks ]
    To quantify changes of the severity of anxiety.The higher the score, the worse the anxiety.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04313530


Locations
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China, Beijing
The Neurology Department of Xuanwu Hospital,Capital Medical University
Beijing, Beijing, China, 100053
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
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Study Chair: Biao Chen, MD,PHD Xuanwu Hospital of Capital Medical University
More Information
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Responsible Party: Piu Chan, Director, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT04313530    
Other Study ID Numbers: 1225435380@qq.com
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Piu Chan, Xuanwu Hospital, Beijing:
TMS,MSA,fMRI,Fatigue,functional, connectivity
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Fatigue
Atrophy
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
 Brain Diseases
Central Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases