iTBS Study for Depression in Patients With Multiple Sclerosis

Sun Yat-sen University

Status: Unknown

Conditions: Multiple Sclerosis; Depression, Anxiety

Treatments: Device: sham intermittent theta burst stimulation using a MagPro X100; Device: intermittent theta burst stimulation using a MagPro X100

Study type: Interventional

Funder types: Other

Identifiers

NCT04524039

02-113-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

iTBS stimulation

Experimental group

Description:

iTBS stimulation to left dorsolateral prefrontal cortex (DLPFC), twice daily, 10 days

Treatment:

Device: intermittent theta burst stimulation using a MagPro X100

sham iTBS stimulation

Sham Comparator group

Description:

sham iTBS stimulation to left dorsolateral prefrontal cortex (DLPFC), twice daily, 10 days

Treatment:

Device: sham intermittent theta burst stimulation using a MagPro X100