iTBS Study for Depression in Patients With Multiple Sclerosis
Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Depression in Patients With Multiple Sclerosis: a Randomized Controlled Study
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- intermittent theta burst stimulation using a MagPro X100
Placebo
- sham intermittent theta burst stimulation using a MagPro X100
What it measured
Main measures
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
0 (baseline), 10 days and 4 weeks
Mood and sleep
Other measures (12)
Presence and changes in severity of side effects
0 (baseline), 10 days and 4 weeks
SafetyChange in Beck Depressive Inventory (BDI)
0 (baseline), 10 days and 4 weeks
Mood and sleepChange in 21-item Beck's Anxiety Inventory (BAI)
0 (baseline), 10 days and 4 weeks
Mood and sleepChange in Fatigue Severity Scale (FSS)
0 (baseline), 10 days and 4 weeks
FatigueChange in Pittsburgh Sleep Quality Index (PSQI)
0 (baseline), 10 days and 4 weeks
Myelin repairMood and sleepChange in Expand Disability Status Scale (EDSS)
0 (baseline), 10 days and 4 weeks
Disability progressionChange in Cortical silent period (CSP) duration
0 (baseline), 10 days and 4 weeks
Change in short-interval intracortical inhibition (SICI)
0 (baseline), 10 days and 4 weeks
Change in intracortical facilitation (ICF)
0 (baseline), 10 days and 4 weeks
Changes in long-interval intracortical inhibition (LICI)
0 (baseline), 10 days and 4 weeks
Who could take part
MS (type not specified) · 18 to 65 · EDSS 0 to 6
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
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.Background
Johansson 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
Boeschoten 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
Siegert 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
Marrie 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
Marrie 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.genBackground
McKay 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
Binzer 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
Blumberger 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
Centonze 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.
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History
Started
Dec 2020
Main results due
Sept 2022
Finished
Dec 2022