Transcranial Magnetic StimulationTMSMSAFNCT04313530
TMS Treatment in Multiple System Atrophy With Fatigue
A study testing Repetitive Transcranial Magnetic Stimulation in people with Transcranial Magnetic Stimulation and Multiple System Atrophy, run by Xuanwu Hospital, Beijing at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Transcranial Magnetic Stimulation, Multiple System Atrophy, Fatigue
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Neurology Department of Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: 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.
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- TMS,MSA,fMRI,Fatigue,functional, connectivity
- Medical subject headings
- Multiple System Atrophy, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
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 group | Role | What they receive |
|---|---|---|
| fatigue in MSA Arm one | Experimental | 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| fatigue in MSA Arm two | Sham comparator | 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Fatigue Severity Scale-9 (FSS-9)
To quantify changes of the severity of fatigue.The higher the score, the worse the fatigue.
Measured: Pre-treatment, post-treatment 0, 2, 4 weeks
Secondary outcomes (2)
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.
Measured: Pre-treatment, post-treatment 0, 2, 4 weeks
Changes in Hamilton Anxiety Scale(HAMA)
To quantify changes of the severity of anxiety.The higher the score, the worse the anxiety.
Measured: Pre-treatment, post-treatment 0, 2, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Oct 2019
- Primary completion1 Jan 2022
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piu Chan, Xuanwu Hospital, Beijing
- Investigators
- Biao Chen, MD,PHD, Study chair, Xuanwu Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313530
- Sponsor's protocol ID
- 1225435380@qq.com
- Acronym
- TMSMSAF
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect and Mechanism of Transcranial Magnetic Stimulation in Multiple System Atrophy Patients With Fatigue
- ClinicalTrials.gov ID
- NCT04313530
- Acronym / sponsor ID
- TMSMSAF / 1225435380@qq.com
- Keywords
- TMS,MSA,fMRI,Fatigue,functional, connectivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fatigue in MSA Arm one | Experimental | Device: Repetitive Transcranial Magnetic StimulationThis 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. |
| fatigue in MSA Arm two | Sham comparator | Device: Repetitive Transcranial Magnetic StimulationThis 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationTranscranial 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. | Device | fatigue in MSA Arm one, fatigue in MSA Arm two |
Primary outcome
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.
2 secondary outcomes
Changes in 17-item Hamilton Depression Scale(HAMD-17)
Time frame: Pre-treatment, post-treatment 0, 2, 4 weeks
Changes in Hamilton Anxiety Scale(HAMA)
Time frame: Pre-treatment, post-treatment 0, 2, 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biao Chen, MD,PHD study chair
Xuanwu Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Transcranial Magnetic Stimulation and Multiple System Atrophy, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Fatigue Severity Scale-9 (FSS-9) (time frame: Pre-treatment, post-treatment 0, 2, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.