Multiple SclerosisNCT04524039
iTBS Study for Depression in Patients With Multiple Sclerosis
A study testing intermittent theta burst stimulation using a MagPro X100 in people with Multiple Sclerosis and Depression, Anxiety, run by Third Affiliated Hospital, Sun Yat-Sen University.
Trial summary
Multiple sclerosis (MS) is a chronic and demyelinating disease of the central nervous system. It is one of the most common cause of neurological disability in young adults. Depression is a common symptom in MS patients, with lifetime prevalence rates going up to 50%. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Depression, Anxiety
- What is being tested?
- intermittent theta burst stimulation using a MagPro X100
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 31 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Age 18 to 65
- 2) Male and female patients with clinically definite MS according to 2017 McDonald criteria
- 3) EDSS 0 to 6
- 4) Score between 11 and 30 on the Montgomery-Asberg Depression Rating Scale (MADRS) and stable antidepressants therapy > 1 months before enrollment and during the follow-up period
- 5) Informed consent of patients
Who cannot join
- 1) History of seizures (personal or family)
- 2) Comedication with neuroleptics or tricyclic antidepressants
- 3) bipolar disorder
- 4) Presence of other diseases of the nervous system (history of stroke, brain injury, brain tumor, increased intracranial pressure)
- 5) Significant neurologic, psychiatric, cardiovascular, hepatic, renal, gastrointestinal, metabolic, or other systemic comorbidities.
- 6) History of drug or alcohol abuse
Show all 9Show fewer
- 7) Cardiac pacemakers
- 8) Metal implants in the head
- 9) Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Depression in Patients With Multiple Sclerosis: a Randomized Controlled Study
Multiple sclerosis (MS) is a chronic and demyelinating disease of the central nervous system. It is one of the most common cause of neurological disability in young adults. Depression is a common symptom in MS patients, with lifetime prevalence rates going up to 50%. Depression not only reduces the response to treatment, delays the recovery of neurological function and social ability, but also significantly increases the risk of disability in patients with MS.
Transcranial magnetic stimulation (TMS) is a non-invasive method of brain stimulation that is based on electromagnetic induction. Intermittent theta burst stimulation (TBS), a newer form of rTMS, delivers 600 pulses in just 3 min, versus 37.5 min for conventional rTMS, but it has been shown to produce similar effects in patient with treatment-resistant depression.
To observe the effect and safety of iTBS on patients with MS and depression, we design a double-blind, randomized controlled study. Results of this research will inform on the efficiency of the TMS for the treatment of depression in MS patients, which will reduce the risk of disability and improve the quality of life.
Read the detailed description
Multiple sclerosis (MS) is a chronic and demyelinating disease of the central nervous system. It is one of the most common cause of neurological disability in young adults. Depression is a common symptom in MS patients, with lifetime prevalence rates going up to 50%. Depression not only reduces the response to treatment, delays the recovery of neurological function and social ability, but also significantly increases the risk of disability in patients with MS. It is worth noting that depression remains widely underdiagnosed and untreated in MS patients. The investigators aim to treat the depression in MS patients using a non-invasive method, which will help improve life quality and reduce the risk of disability in patients.
Transcranial magnetic stimulation (TMS) is a non-invasive method of brain stimulation that uses magnetic fields to stimulate nerve cells in brain. Repetitive TMS (rTMS) is usually applied in antidepressant-resistant depression. Furthermore, some clinical trials show that rTMS also significantly improve Parkinson's related depression and postpartum depression. Intermittent theta burst stimulation (TBS), a newer form of rTMS, delivers 600 pulses in just 3 min, versus 37.5 min for conventional rTMS, but it has been shown to produce similar effects in patient with treatment-resistant depression.
In this study, thirty patients who meet the criteria will be included. They will then be randomly assigned into the SHAM or iTBS group for the study intervention. Patients and outcome assessors will be masked to treatment allocation. SHAM or iTBS will be delivered to stimulate left dorsalateral prefrontal cortex (DLPFC). The protocol includes 600 pulses per session: triplet 50 Hz bursts, repeated at 5 Hz; 2 s on and 8 s off. Each patient will receive 2 sessions per day over a period of 10 days (total of 20 sessions). After the treatment phase, patients will be followed up once after two weeks. The presence and severity of side effects will be assessed by the physician from the Department of Neurology. Before and after the iTBS or SHAM intervention and after two weeks of follow-up, primary and secondary measurements will be performed.
Results of this study will inform on the efficiency of the TMS for the treatment of depression in MS patients, which will reduce the risk of disability and improve the quality of life.
- Conditions
- Multiple Sclerosis, Depression, Anxiety
- Being tested
- intermittent theta burst stimulation using a MagPro X100, sham intermittent theta burst stimulation using a MagPro X100
- Keywords
- Multiple Sclerosis, Depression, Transcranial Magnetic Stimulation
- Medical subject headings
- Multiple Sclerosis, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent theta burst stimulation using a MagPro X100Device
Patients randomized to receive iTBS in left dorsolateral prefrontal cortex, each treatment will consist of 600 stimuli (triplet 50 Hz bursts, repeated at 5 Hz; 2 s on and 8 s off; total duration of 3 min 12 s). Simulated iTBS will be administered using Magventure static cooling MCF-B65 coil.
sham intermittent theta burst stimulation using a MagPro X100Device
Patients randomized to receive sham iTBS will undergo the same procedure to patients receiving real iTBS. Sham iTBS will be administered using Magventure static cooling MCF-P-B65 coil that shares the same mechanical outline and produces identical sound level to MCF-B65 coil without stimulating the cerebral cortex.
| Study group | Role | What they receive |
|---|---|---|
| iTBS stimulation | Experimental | iTBS stimulation to left dorsolateral prefrontal cortex (DLPFC), twice daily, 10 days Receives: Device: intermittent theta burst stimulation using a MagPro X100 |
| sham iTBS stimulation | Sham comparator | sham iTBS stimulation to left dorsolateral prefrontal cortex (DLPFC), twice daily, 10 days Receives: Device: sham intermittent theta burst stimulation using a MagPro X100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
The MADRS is a 0-60 point scale to measure depression severity with a higher number indicating more severe depression. A score of 0-6 indicates symptoms absent, 7-19 indicates mild depression, 20-34 moderate, and > 34 severe.
Measured: 0 (baseline), 10 days and 4 weeks
Secondary outcomes (12)
Presence and changes in severity of side effects
Adverse events will be assessed by the physician from Department of Neurology weekly.
Measured: 0 (baseline), 10 days and 4 weeks
Change in Beck Depressive Inventory (BDI)
BDI is a widely utilized to assess depression in MS patients. It is a 21-item self-reporting questionnaire for evaluating the severity of depression. The score range is 0-63 with higher scores indicating higher intensity.
Measured: 0 (baseline), 10 days and 4 weeks
Change in 21-item Beck's Anxiety Inventory (BAI)
BAI is a self-report test for measuring anxiety severity and level. It contains 21 multiple-choice questions. The score range is 0-63 with higher scores indicating higher intensity.
Measured: 0 (baseline), 10 days and 4 weeks
Change in Fatigue Severity Scale (FSS)
The FSS is a 9-item scale which measure the severity of fatigue and its effect on an individual's daily living and social participation. The total score ranges from 9 to 63, with a higher score indicate greater fatigue severity.
Measured: 0 (baseline), 10 days and 4 weeks
Change in Pittsburgh Sleep Quality Index (PSQI)
PSQI is a self-rated questionnaire designed to evaluate overall sleep quality during the past month. Each of the questionnaire's 19 self-reported items belongs to one of seven subcategories: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep medication, degree of daytime dysfunction.
Measured: 0 (baseline), 10 days and 4 weeks
Change in Expand Disability Status Scale (EDSS)
EDSS is a standardized method used to classify the severity and progression of multiple sclerosis. It provides a total score on a scale that ranges from 0 to 10.
Measured: 0 (baseline), 10 days and 4 weeks
Change in Cortical silent period (CSP) duration
CSP duration will be measured by Magventure X100 + option.
Measured: 0 (baseline), 10 days and 4 weeks
Change in short-interval intracortical inhibition (SICI)
SICI will be measured by Magventure X100 + option.
Measured: 0 (baseline), 10 days and 4 weeks
Change in intracortical facilitation (ICF)
ICF will be measured by Magventure X100 + option.
Measured: 0 (baseline), 10 days and 4 weeks
Changes in long-interval intracortical inhibition (LICI)
LICI will be measured by Magventure X100 + option.
Measured: 0 (baseline), 10 days and 4 weeks
Change in slow-wave/fast-wave (theta/beta) ratio from resting-state electroencephalograph (EEG) recording
Resting-state EEG will be recorded by Nicolet EEG system.
Measured: 0 (baseline), 10 days and 4 weeks
Serum biomarker
Serum biomarker such as BDNF, TNF-alpha, IL-1 beta, S100 beta will be examined before and after TMS treatment.
Measured: 0 (baseline), 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Qiu, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Wei Qiu, MD/Ph.D, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen UniversityLiqing Wang, MD/Ph.D, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524039
- Sponsor's protocol ID
- 02-113-01
- Status last verified
- Nov 2020
- First submitted
- 2 Aug 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoang H, Laursen B, Stenager EN, Stenager E. Psychiatric co-morbidity in multiple sclerosis: The risk of depression and anxiety before and after MS diagnosis. Mult Scler. 2016 Mar;22(3):347-53. doi: 10.1177/1352458515588973. Epub 2015 Jun 3.
PubMed 26041803Johansson V, Lundholm C, Hillert J, Masterman T, Lichtenstein P, Landen M, Hultman CM. Multiple sclerosis and psychiatric disorders: comorbidity and sibling risk in a nationwide Swedish cohort. Mult Scler. 2014 Dec;20(14):1881-91. doi: 10.1177/1352458514540970. Epub 2014 Jul 10.
PubMed 25013151Boeschoten RE, Braamse AMJ, Beekman ATF, Cuijpers P, van Oppen P, Dekker J, Uitdehaag BMJ. Prevalence of depression and anxiety in Multiple Sclerosis: A systematic review and meta-analysis. J Neurol Sci. 2017 Jan 15;372:331-341. doi: 10.1016/j.jns.2016.11.067. Epub 2016 Nov 30.
PubMed 28017241Siegert RJ, Abernethy DA. Depression in multiple sclerosis: a review. J Neurol Neurosurg Psychiatry. 2005 Apr;76(4):469-75. doi: 10.1136/jnnp.2004.054635.
PubMed 15774430Marrie RA, Fisk JD, Tremlett H, Wolfson C, Warren S, Tennakoon A, Leung S, Patten SB; CIHR Team in the Epidemiology and Impact of Comorbidity on Multiple Sclerosis. Differences in the burden of psychiatric comorbidity in MS vs the general population. Neurology. 2015 Dec 1;85(22):1972-9. doi: 10.1212/WNL.0000000000002174. Epub 2015 Oct 30.
PubMed 26519542Marrie RA, Walld R, Bolton JM, Sareen J, Patten SB, Singer A, Lix LM, Hitchon CA, El-Gabalawy R, Katz A, Fisk JD, Bernstein CN; CIHR Team in Defining the Burden and Managing the Effects of Psychiatric Comorbidity in Chronic Immunoinflammatory Disease. Psychiatric comorbidity increases mortality in immune-mediated inflammatory diseases. Gen Hosp Psychiatry. 2018 Jul-Aug;53:65-72. doi: 10.1016/j.genhosppsych.2018.06.001. Epub 2018 Jun 7.
PubMed 29929117McKay KA, Tremlett H, Fisk JD, Zhang T, Patten SB, Kastrukoff L, Campbell T, Marrie RA; CIHR Team in the Epidemiology and Impact of Comorbidity on Multiple Sclerosis. Psychiatric comorbidity is associated with disability progression in multiple sclerosis. Neurology. 2018 Apr 10;90(15):e1316-e1323. doi: 10.1212/WNL.0000000000005302. Epub 2018 Mar 9.
PubMed 29523642Binzer S, McKay KA, Brenner P, Hillert J, Manouchehrinia A. Disability worsening among persons with multiple sclerosis and depression: A Swedish cohort study. Neurology. 2019 Dec 10;93(24):e2216-e2223. doi: 10.1212/WNL.0000000000008617. Epub 2019 Nov 8.
PubMed 31704791Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
PubMed 29726344Centonze D, Koch G, Versace V, Mori F, Rossi S, Brusa L, Grossi K, Torelli F, Prosperetti C, Cervellino A, Marfia GA, Stanzione P, Marciani MG, Boffa L, Bernardi G. Repetitive transcranial magnetic stimulation of the motor cortex ameliorates spasticity in multiple sclerosis. Neurology. 2007 Mar 27;68(13):1045-50. doi: 10.1212/01.wnl.0000257818.16952.62.
PubMed 17389310Gaede G, Tiede M, Lorenz I, Brandt AU, Pfueller C, Dorr J, Bellmann-Strobl J, Piper SK, Roth Y, Zangen A, Schippling S, Paul F. Safety and preliminary efficacy of deep transcranial magnetic stimulation in MS-related fatigue. Neurol Neuroimmunol Neuroinflamm. 2017 Dec 13;5(1):e423. doi: 10.1212/NXI.0000000000000423. eCollection 2018 Jan.
PubMed 29259998Hulst HE, Goldschmidt T, Nitsche MA, de Wit SJ, van den Heuvel OA, Barkhof F, Paulus W, van der Werf YD, Geurts JJG. rTMS affects working memory performance, brain activation and functional connectivity in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 May;88(5):386-394. doi: 10.1136/jnnp-2016-314224. Epub 2016 Dec 14.
PubMed 27974394
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Depression in Patients With Multiple Sclerosis: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04524039
- Acronym / sponsor ID
- 02-113-01
- Conditions
- Multiple Sclerosis, Depression, Anxiety
- Keywords
- Multiple Sclerosis, Depression, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Aug 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.
Multiple sclerosis (MS) is a chronic and demyelinating disease of the central nervous system. It is one of the most common cause of neurological disability in young adults. Depression is a common symptom in MS patients, with lifetime prevalence rates going up to 50%. Depression not only reduces the response to treatment, delays the recovery of neurological function and social ability, but also significantly increases the risk of disability in patients with MS.
Transcranial magnetic stimulation (TMS) is a non-invasive method of brain stimulation that is based on electromagnetic induction. Intermittent theta burst stimulation (TBS), a newer form of rTMS, delivers 600 pulses in just 3 min, versus 37.5 min for conventional rTMS, but it has been shown to produce similar effects in patient with treatment-resistant depression.
To observe the effect and safety of iTBS on patients with MS and depression, we design a double-blind, randomized controlled study. Results of this research will inform on the efficiency of the TMS for the treatment of depression in MS patients, which will reduce the risk of disability and improve the quality of life.
Detailed description
Multiple sclerosis (MS) is a chronic and demyelinating disease of the central nervous system. It is one of the most common cause of neurological disability in young adults. Depression is a common symptom in MS patients, with lifetime prevalence rates going up to 50%. Depression not only reduces the response to treatment, delays the recovery of neurological function and social ability, but also significantly increases the risk of disability in patients with MS. It is worth noting that depression remains widely underdiagnosed and untreated in MS patients. The investigators aim to treat the depression in MS patients using a non-invasive method, which will help improve life quality and reduce the risk of disability in patients.
Transcranial magnetic stimulation (TMS) is a non-invasive method of brain stimulation that uses magnetic fields to stimulate nerve cells in brain. Repetitive TMS (rTMS) is usually applied in antidepressant-resistant depression. Furthermore, some clinical trials show that rTMS also significantly improve Parkinson's related depression and postpartum depression. Intermittent theta burst stimulation (TBS), a newer form of rTMS, delivers 600 pulses in just 3 min, versus 37.5 min for conventional rTMS, but it has been shown to produce similar effects in patient with treatment-resistant depression.
In this study, thirty patients who meet the criteria will be included. They will then be randomly assigned into the SHAM or iTBS group for the study intervention. Patients and outcome assessors will be masked to treatment allocation. SHAM or iTBS will be delivered to stimulate left dorsalateral prefrontal cortex (DLPFC). The protocol includes 600 pulses per session: triplet 50 Hz bursts, repeated at 5 Hz; 2 s on and 8 s off. Each patient will receive 2 sessions per day over a period of 10 days (total of 20 sessions). After the treatment phase, patients will be followed up once after two weeks. The presence and severity of side effects will be assessed by the physician from the Department of Neurology. Before and after the iTBS or SHAM intervention and after two weeks of follow-up, primary and secondary measurements will be performed.
Results of this study will inform on the efficiency of the TMS for the treatment of depression in MS patients, which will reduce the risk of disability and improve the quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iTBS stimulation | Experimental | Device: intermittent theta burst stimulation using a MagPro X100iTBS stimulation to left dorsolateral prefrontal cortex (DLPFC), twice daily, 10 days |
| sham iTBS stimulation | Sham comparator | Device: sham intermittent theta burst stimulation using a MagPro X100sham iTBS stimulation to left dorsolateral prefrontal cortex (DLPFC), twice daily, 10 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1) Age 18 to 65
- 2) Male and female patients with clinically definite MS according to 2017 McDonald criteria
- 3) EDSS 0 to 6
- 4) Score between 11 and 30 on the Montgomery-Asberg Depression Rating Scale (MADRS) and stable antidepressants therapy > 1 months before enrollment and during the follow-up period
- 5) Informed consent of patients
Key exclusion criteria (9 listed)
- 1) History of seizures (personal or family)
- 2) Comedication with neuroleptics or tricyclic antidepressants
- 3) bipolar disorder
- 4) Presence of other diseases of the nervous system (history of stroke, brain injury, brain tumor, increased intracranial pressure)
- 5) Significant neurologic, psychiatric, cardiovascular, hepatic, renal, gastrointestinal, metabolic, or other systemic comorbidities.
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 |
|---|---|---|
| intermittent theta burst stimulation using a MagPro X100Patients randomized to receive iTBS in left dorsolateral prefrontal cortex, each treatment will consist of 600 stimuli (triplet 50 Hz bursts, repeated at 5 Hz; 2 s on and 8 s off; total duration of 3 min 12 s). Simulated iTBS will be administered using Magventure static cooling MCF-B65 coil. | Device | iTBS stimulation |
| sham intermittent theta burst stimulation using a MagPro X100Patients randomized to receive sham iTBS will undergo the same procedure to patients receiving real iTBS. Sham iTBS will be administered using Magventure static cooling MCF-P-B65 coil that shares the same mechanical outline and produces identical sound level to MCF-B65 coil without stimulating the cerebral cortex. | Device | sham iTBS stimulation |
Primary outcome
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 0 (baseline), 10 days and 4 weeks
The MADRS is a 0-60 point scale to measure depression severity with a higher number indicating more severe depression. A score of 0-6 indicates symptoms absent, 7-19 indicates mild depression, 20-34 moderate, and > 34 severe.
12 secondary outcomes
Presence and changes in severity of side effects
Time frame: 0 (baseline), 10 days and 4 weeks
Change in Beck Depressive Inventory (BDI)
Time frame: 0 (baseline), 10 days and 4 weeks
Change in 21-item Beck's Anxiety Inventory (BAI)
Time frame: 0 (baseline), 10 days and 4 weeks
Change in Fatigue Severity Scale (FSS)
Time frame: 0 (baseline), 10 days and 4 weeks
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: 0 (baseline), 10 days and 4 weeks
Change in Expand Disability Status Scale (EDSS)
Time frame: 0 (baseline), 10 days and 4 weeks
Change in Cortical silent period (CSP) duration
Time frame: 0 (baseline), 10 days and 4 weeks
Change in short-interval intracortical inhibition (SICI)
Time frame: 0 (baseline), 10 days and 4 weeks
Change in intracortical facilitation (ICF)
Time frame: 0 (baseline), 10 days and 4 weeks
Changes in long-interval intracortical inhibition (LICI)
Time frame: 0 (baseline), 10 days and 4 weeks
Change in slow-wave/fast-wave (theta/beta) ratio from resting-state electroencephalograph (EEG) recording
Time frame: 0 (baseline), 10 days and 4 weeks
Serum biomarker
Time frame: 0 (baseline), 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Background: PubMed 26041803Hoang H, Laursen B, Stenager EN, Stenager E. Psychiatric co-morbidity in multiple sclerosis: The risk of depression and anxiety before and after MS diagnosis. Mult Scler. 2016 Mar;22(3):347-53. doi: 10.1177/1352458515588973. Epub 2015 Jun 3.
- Background: PubMed 25013151Johansson V, Lundholm C, Hillert J, Masterman T, Lichtenstein P, Landen M, Hultman CM. Multiple sclerosis and psychiatric disorders: comorbidity and sibling risk in a nationwide Swedish cohort. Mult Scler. 2014 Dec;20(14):1881-91. doi: 10.1177/1352458514540970. Epub 2014 Jul 10.
- Background: PubMed 28017241Boeschoten RE, Braamse AMJ, Beekman ATF, Cuijpers P, van Oppen P, Dekker J, Uitdehaag BMJ. Prevalence of depression and anxiety in Multiple Sclerosis: A systematic review and meta-analysis. J Neurol Sci. 2017 Jan 15;372:331-341. doi: 10.1016/j.jns.2016.11.067. Epub 2016 Nov 30.
- Background: PubMed 15774430Siegert RJ, Abernethy DA. Depression in multiple sclerosis: a review. J Neurol Neurosurg Psychiatry. 2005 Apr;76(4):469-75. doi: 10.1136/jnnp.2004.054635.
- Background: PubMed 26519542Marrie RA, Fisk JD, Tremlett H, Wolfson C, Warren S, Tennakoon A, Leung S, Patten SB; CIHR Team in the Epidemiology and Impact of Comorbidity on Multiple Sclerosis. Differences in the burden of psychiatric comorbidity in MS vs the general population. Neurology. 2015 Dec 1;85(22):1972-9. doi: 10.1212/WNL.0000000000002174. Epub 2015 Oct 30.
- Background: PubMed 29929117Marrie RA, Walld R, Bolton JM, Sareen J, Patten SB, Singer A, Lix LM, Hitchon CA, El-Gabalawy R, Katz A, Fisk JD, Bernstein CN; CIHR Team in Defining the Burden and Managing the Effects of Psychiatric Comorbidity in Chronic Immunoinflammatory Disease. Psychiatric comorbidity increases mortality in immune-mediated inflammatory diseases. Gen Hosp Psychiatry. 2018 Jul-Aug;53:65-72. doi: 10.1016/j.genhosppsych.2018.06.001. Epub 2018 Jun 7.
- Background: PubMed 29523642McKay KA, Tremlett H, Fisk JD, Zhang T, Patten SB, Kastrukoff L, Campbell T, Marrie RA; CIHR Team in the Epidemiology and Impact of Comorbidity on Multiple Sclerosis. Psychiatric comorbidity is associated with disability progression in multiple sclerosis. Neurology. 2018 Apr 10;90(15):e1316-e1323. doi: 10.1212/WNL.0000000000005302. Epub 2018 Mar 9.
- Background: PubMed 31704791Binzer S, McKay KA, Brenner P, Hillert J, Manouchehrinia A. Disability worsening among persons with multiple sclerosis and depression: A Swedish cohort study. Neurology. 2019 Dec 10;93(24):e2216-e2223. doi: 10.1212/WNL.0000000000008617. Epub 2019 Nov 8.
- Background: PubMed 29726344Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
- Background: PubMed 17389310Centonze D, Koch G, Versace V, Mori F, Rossi S, Brusa L, Grossi K, Torelli F, Prosperetti C, Cervellino A, Marfia GA, Stanzione P, Marciani MG, Boffa L, Bernardi G. Repetitive transcranial magnetic stimulation of the motor cortex ameliorates spasticity in multiple sclerosis. Neurology. 2007 Mar 27;68(13):1045-50. doi: 10.1212/01.wnl.0000257818.16952.62.
- Background: PubMed 29259998Gaede G, Tiede M, Lorenz I, Brandt AU, Pfueller C, Dorr J, Bellmann-Strobl J, Piper SK, Roth Y, Zangen A, Schippling S, Paul F. Safety and preliminary efficacy of deep transcranial magnetic stimulation in MS-related fatigue. Neurol Neuroimmunol Neuroinflamm. 2017 Dec 13;5(1):e423. doi: 10.1212/NXI.0000000000000423. eCollection 2018 Jan.
- Background: PubMed 27974394Hulst HE, Goldschmidt T, Nitsche MA, de Wit SJ, van den Heuvel OA, Barkhof F, Paulus W, van der Werf YD, Geurts JJG. rTMS affects working memory performance, brain activation and functional connectivity in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 May;88(5):386-394. doi: 10.1136/jnnp-2016-314224. Epub 2016 Dec 14.
- Individual participant dataSharing planned: No
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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.
Wei Qiu, MD/Ph.D principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
Liqing Wang, MD/Ph.D principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A study testing intermittent theta burst stimulation using a MagPro X100 in people with Multiple Sclerosis and Depression, Anxiety, run by Third Affiliated Hospital, Sun Yat-Sen University.
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 5 inclusion and 9 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 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Wei Qiu, MD/Ph.D (+8615899968330, qiuwei120@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: 0 (baseline), 10 days and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04524039, which also lists 12 linked publications.
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 24 Nov 2020.