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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

Tracking Information
First Submitted Date  ICMJE March 16, 2020
First Posted Date  ICMJE March 18, 2020
Last Update Posted Date April 6, 2022
Actual Study Start Date  ICMJE October 1, 2019
Actual Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2022)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2020)
Changes in Fatigue Severity Scale (FSS) [ Time Frame: Pre-treatment, post-treatment 0, 2, 4 weeks ]
To quantify changes of the severity of fatigue.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2022)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2020)
  • Changes in HAMD [ Time Frame: Pre-treatment, post-treatment 0, 2, 4 weeks ]
    To quantify changes of the severity of depression
  • Changes in HAMA [ Time Frame: Pre-treatment, post-treatment 0, 2, 4 weeks ]
    To quantify changes of the severity of anxiety.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TMS Treatment in Multiple System Atrophy With Fatigue
Official Title  ICMJE Study on the Effect and Mechanism of Transcranial Magnetic Stimulation in Multiple System Atrophy Patients With Fatigue
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Transcranial Magnetic Stimulation
  • Multiple System Atrophy
  • Fatigue
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Repetitive Transcranial Magnetic Stimulation
  • 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.
    Intervention: Device: Repetitive Transcranial Magnetic Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: March 17, 2020)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2022
Actual Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04313530
Other Study ID Numbers  ICMJE 1225435380@qq.com
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Piu Chan, Xuanwu Hospital, Beijing
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Xuanwu Hospital, Beijing
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Biao Chen, MD,PHD Xuanwu Hospital of Capital Medical University
PRS Account Xuanwu Hospital, Beijing
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP