TMS Treatment in Multiple System Atrophy With Fatigue (TMSMSAF)

• ClinicalTrials.gov Identifier: NCT04313530
• Recruitment Status: Enrolling by invitation
• First Posted: March 18, 2020
• Last Update Posted: April 6, 2022
• Sponsor: Xuanwu Hospital, Beijing
• Information provided by (Responsible Party): Piu Chan, Xuanwu Hospital, Beijing

Tracking Information

• First Submitted Date: March 16, 2020
• First Posted Date: March 18, 2020
• Last Update Posted Date: April 6, 2022
• Actual Study Start Date: October 1, 2019
• Actual Primary Completion Date: January 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: 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

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Transcranial Magnetic Stimulation
• Multiple System Atrophy
• Fatigue

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: March 17, 2020): 22
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 1, 2022
• Actual Primary Completion Date: January 1, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04313530
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Piu Chan, Xuanwu Hospital, Beijing
• Original Responsible Party: Same as current
• Current Study Sponsor: Xuanwu Hospital, Beijing
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Biao Chen, MD,PHD; Xuanwu Hospital of Capital Medical University

• PRS Account: Xuanwu Hospital, Beijing
• Verification Date: March 2022