Multiple Sclerosis Clinical Trial
Official title:
Pilot Study of the Safety and Tolerability of Left Dorsolateral Prefrontal Cortex Intermittent Theta Burst rTMS for Major Depressive Disorder in Multiple Sclerosis
NCT number | NCT04621708 |
Other study ID # | 1563 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 30, 2020 |
Est. completion date | April 30, 2024 |
The main purpose of this study is to investigate the safety and tolerability of intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS), its effectiveness in alleviating depressive symptoms as well as its effects on cognition. Although iTBS rTMS is approved for use, there have been no safety and tolerability evaluations of this form of rTMS in Multiple Sclerosis (MS).
Status | Recruiting |
Enrollment | 20 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion criteria 1. Men and women =18 and =70 years of age, inclusive. 2. History of MS confirmed by a neurologist. 3. Patients who are able and willing to give consent and able to adhere to treatment schedule and attend study visits, as determined by study psychiatrist 4. DSM-V diagnosis of Major Depressive Disorder (MDD) 5. Moderate severity with a Hamilton Depression Rating Scale (HAMD) at least 16 6. Patients have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening 7. Pass the TMS safety screening questionnaire 8. Women of childbearing potential must agree to use a barrier contraception method throughout the study. Exclusion criteria 1. Active substance abuse or dependence in the last three months, except nicotine 2. Active suicidal intent 3. Currently pregnant (as determined by history and serum HCG) or lactating. 4. A diagnosis of Bipolar Disorder 5. A history of past or current psychotic symptoms 6. Diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), assessed by a study investigator to be primary and causing greater impairment than MDD 7. Having failed a course of ECT in the current episode or previous episode 8. Previous trial of rTMS 9. Personality disorder deemed to be primary pathology 10. If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study 11. Clinically significant laboratory abnormality, in the opinion of the investigator 12. Unstable medical illness 13. Contraindication to rTMS, e.g. presence of cardiac pacemaker, intracranial implant, or metal in the cranium 14. Currently on more than 2 mg of lorazepam or equivalent 15. History of seizures, or currently on anticonvulsant for seizures 16. Concurrent use of a medication that may lower the seizure threshold, in the opinion of the investigator e.g. stimulant. |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in depressive symptoms | The primary outcome measure will be the reduction in depressive symptoms as measured by the Hamilton Depression Rating Scale-17 at the end of the 4-week trial of iTBS rTMS. This will be measured as both a continuous variable (score on HAMD-17 at week 4 - score on HAMD-17 at week 0 pre-treatment) and a categorical one (i.e. the response rates of >50% reduction from baseline HAMD-17 and remission rates defined as HAMD-17 <7). | Baseline and 4 weeks post-treatment | |
Secondary | Change in anxiety and depressive symptoms | Change in anxiety and depressive symptoms as measured by the self-report Hospital Anxiety and Depression Scale (HADS)-17 at the end of the 4-week trial of iTBS rTMS. | Baseline and 4 weeks post-treatment | |
Secondary | Change in fatigue, severity and impact | Change in fatigue, severity and impact, measured by the self-report Fatigue Severity Scale (FSS) | Baseline and 4 weeks post-treatment | |
Secondary | Change in Neuropsychological function | Change in Neuropsychological function, measured subjectively through the Perceived Deficits Questionnaire (PDQ-5) and objectively by the SDMT and computerized CANTAB neuropsychological tasks | Baseline and 4 weeks post-treatment | |
Secondary | Change in fatigue, severity and impact | Change in fatigue, severity and impact, measured by the Modified Fatigue Impact Scale (MFIS), respectively | Baseline and 4 weeks post-treatment | |
Secondary | Change in Neuropsychological function | Change in Neuropsychological function, measured objectively by the computerized CANTAB neuropsychological tasks | Baseline and 4 weeks post-treatment |
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