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TMS Treatment in Multiple System Atrophy With Fatigue (TMSMSAF)

Primary Purpose

Transcranial Magnetic Stimulation, Multiple System Atrophy, Fatigue

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transcranial Magnetic Stimulation focused on measuring TMS,MSA,fMRI,Fatigue,functional, connectivity

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Neurology Department of Xuanwu Hospital,Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

fatigue in MSA Arm one

fatigue in MSA Arm two

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in Fatigue Severity Scale-9 (FSS-9)
To quantify changes of the severity of fatigue.The higher the score, the worse the fatigue.

Secondary Outcome Measures

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.
Changes in Hamilton Anxiety Scale(HAMA)
To quantify changes of the severity of anxiety.The higher the score, the worse the anxiety.

Full Information

First Posted
March 16, 2020
Last Updated
March 26, 2022
Sponsor
Xuanwu Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT04313530
Brief Title
TMS Treatment in Multiple System Atrophy With Fatigue
Acronym
TMSMSAF
Official Title
Study on the Effect and Mechanism of Transcranial Magnetic Stimulation in Multiple System Atrophy Patients With Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuanwu Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Magnetic Stimulation, Multiple System Atrophy, Fatigue
Keywords
TMS,MSA,fMRI,Fatigue,functional, connectivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fatigue in MSA Arm one
Arm Type
Experimental
Arm Description
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.
Arm Title
fatigue in MSA Arm two
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Fatigue Severity Scale-9 (FSS-9)
Description
To quantify changes of the severity of fatigue.The higher the score, the worse the fatigue.
Time Frame
Pre-treatment, post-treatment 0, 2, 4 weeks
Secondary Outcome Measure Information:
Title
Changes in 17-item Hamilton Depression Scale(HAMD-17)
Description
To quantify changes of the severity of depression.The higher the score, the worse the depression.
Time Frame
Pre-treatment, post-treatment 0, 2, 4 weeks
Title
Changes in Hamilton Anxiety Scale(HAMA)
Description
To quantify changes of the severity of anxiety.The higher the score, the worse the anxiety.
Time Frame
Pre-treatment, post-treatment 0, 2, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biao Chen, MD,PHD
Organizational Affiliation
Xuanwu Hospital of Capital Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The Neurology Department of Xuanwu Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China

12. IPD Sharing Statement

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TMS Treatment in Multiple System Atrophy With Fatigue

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