Pilot Study of the Safety and Tolerability of L-DLPFC iTBS rTMS for MD
Pilot Study of the Safety and Tolerability of Left Dorsolateral Prefrontal Cortex Intermittent Theta Burst rTMS for Major Depressive Disorder in Multiple Sclerosis
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
- Repetitive transcranial magnetic stimulation
What it measured
Main measures
Change in depressive symptoms
Baseline and 4 weeks post-treatment
Mood and sleep
Other measures (3)
Change in anxiety and depressive symptoms
Baseline and 4 weeks post-treatment
Mood and sleepChange in fatigue, severity and impact
Baseline and 4 weeks post-treatment
FatigueChange in Neuropsychological function
Baseline and 4 weeks post-treatment
Thinking and memory
Who could take part
MS (type not specified) · 18 to 70
Show the full criteria
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
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History
Started
Apr 2020
Main results due
Apr 2024
Finished
Apr 2024