- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04313530
TMS Treatment in Multiple System Atrophy With Fatigue (TMSMSAF)
Study on the Effect and Mechanism of Transcranial Magnetic Stimulation in Multiple System Atrophy Patients With Fatigue
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100053
- The Neurology Department of Xuanwu Hospital,Capital Medical University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Pre-treatment, post-treatment 0, 2, 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Pre-treatment, post-treatment 0, 2, 4 weeks
|
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.
|
Pre-treatment, post-treatment 0, 2, 4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Pathological Conditions, Anatomical
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Hypotension
- Fatigue
- Atrophy
- Multiple System Atrophy
- Shy-Drager Syndrome
Other Study ID Numbers
- 1225435380@qq.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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