iTBS Study for Depression in Patients With Multiple Sclerosis
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| ClinicalTrials.gov Identifier: NCT04524039 |
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Recruitment Status :
Not yet recruiting
First Posted : August 24, 2020
Last Update Posted : November 24, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Sclerosis Depression, Anxiety | Device: intermittent theta burst stimulation using a MagPro X100 Device: sham intermittent theta burst stimulation using a MagPro X100 | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Depression in Patients With Multiple Sclerosis: a Randomized Controlled Study |
| Estimated Study Start Date : | December 1, 2020 |
| Estimated Primary Completion Date : | September 1, 2022 |
| Estimated Study Completion Date : | December 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: iTBS stimulation
iTBS stimulation to left dorsolateral prefrontal cortex (DLPFC), twice daily, 10 days
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Device: intermittent theta burst stimulation using a MagPro X100
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. |
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Sham Comparator: sham iTBS stimulation
sham iTBS stimulation to left dorsolateral prefrontal cortex (DLPFC), twice daily, 10 days
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Device: sham intermittent theta burst stimulation using a MagPro X100
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. |
- 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.
- Presence and changes in severity of side effects [ Time Frame: 0 (baseline), 10 days and 4 weeks ]Adverse events will be assessed by the physician from Department of Neurology weekly.
- Change in Beck Depressive Inventory (BDI) [ Time Frame: 0 (baseline), 10 days and 4 weeks ]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.
- Change in 21-item Beck's Anxiety Inventory (BAI) [ Time Frame: 0 (baseline), 10 days and 4 weeks ]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.
- Change in Fatigue Severity Scale (FSS) [ Time Frame: 0 (baseline), 10 days and 4 weeks ]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.
- Change in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 0 (baseline), 10 days and 4 weeks ]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.
- Change in Expand Disability Status Scale (EDSS) [ Time Frame: 0 (baseline), 10 days and 4 weeks ]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.
- Change in Cortical silent period (CSP) duration [ Time Frame: 0 (baseline), 10 days and 4 weeks ]CSP duration will be measured by Magventure X100 + option.
- Change in short-interval intracortical inhibition (SICI) [ Time Frame: 0 (baseline), 10 days and 4 weeks ]SICI will be measured by Magventure X100 + option.
- Change in intracortical facilitation (ICF) [ Time Frame: 0 (baseline), 10 days and 4 weeks ]ICF will be measured by Magventure X100 + option.
- Changes in long-interval intracortical inhibition (LICI) [ Time Frame: 0 (baseline), 10 days and 4 weeks ]LICI will be measured by Magventure X100 + option.
- Change in slow-wave/fast-wave (theta/beta) ratio from resting-state electroencephalograph (EEG) recording [ Time Frame: 0 (baseline), 10 days and 4 weeks ]Resting-state EEG will be recorded by Nicolet EEG system.
- Serum biomarker [ Time Frame: 0 (baseline), 10 days ]Serum biomarker such as BDNF, TNF-alpha, IL-1 beta, S100 beta will be examined before and after TMS treatment.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 7) Cardiac pacemakers
- 8) Metal implants in the head
- 9) Pregnancy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524039
| Contact: Wei Qiu, MD/Ph.D | +8615899968330 | qiuwei120@vip.163.com | |
| Contact: Liqing Wang, MD/Ph.D | +86(20)85253088 | wanglq5@mail.sysu.edu.cn |
| Principal Investigator: | Wei Qiu, MD/Ph.D | Third Affiliated Hospital, Sun Yat-Sen University | |
| Principal Investigator: | Liqing Wang, MD/Ph.D | Third Affiliated Hospital, Sun Yat-Sen University |
| Responsible Party: | Wei Qiu, Professor, MD, Ph.D, Third Affiliated Hospital, Sun Yat-Sen University |
| ClinicalTrials.gov Identifier: | NCT04524039 |
| Other Study ID Numbers: |
02-113-01 |
| First Posted: | August 24, 2020 Key Record Dates |
| Last Update Posted: | November 24, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Multiple Sclerosis Depression Transcranial Magnetic Stimulation |
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Multiple Sclerosis Sclerosis Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |