TMS Treatment in Multiple System Atrophy With Fatigue

Fatigue Clinical Trial

— TMSMSAF  

Official title:

Study on the Effect and Mechanism of Transcranial Magnetic Stimulation in Multiple System Atrophy Patients With Fatigue

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04313530
• Other study ID #: 1225435380@qq.com
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: May 1, 2022

Study information

• Verified date: March 2022
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 22
• Est. completion date: May 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Fatigue
• Multiple System Atrophy
• Shy-Drager Syndrome
• Transcranial Magnetic Stimulation

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.

Locations

Country	Name	City	State
China	The Neurology Department of Xuanwu Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Fatigue Severity Scale-9 (FSS-9)	To quantify changes of the severity of fatigue.The higher the score, the worse the fatigue.	Pre-treatment, post-treatment 0, 2, 4 weeks
Secondary	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.	Pre-treatment, post-treatment 0, 2, 4 weeks
Secondary	Changes in Hamilton Anxiety Scale(HAMA)	To quantify changes of the severity of anxiety.The higher the score, the worse the anxiety.	Pre-treatment, post-treatment 0, 2, 4 weeks