Clinical trial NCT06157333: Efficacy of Accelerated Repetitive Transcranial Magnetic Stimulation on Patients With Post-stroke Depression
Official title: Effect of Accelerated Repetitive Transcranial Magnetic Stimulation on Depression Symptoms in Patients With Subacute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke Depression
Keywords: Accelerated rTMS
Repetitive Transcranial Magnetic Stimulation
Post-stroke Depression
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The FDA approved repetitive transcranial magnetic stimulation (rTMS) for patients with Major Depressive Disorder (MDD) in 2008. The conventional rTMS protocol that has been used effectively for major depression is 5 days per week for 4-6 weeks. The accelerated rTMS protocol involves conducting more than one session per day. In the treatment of post-stroke depression (PSD); although the effectiveness of conventional rTMS procedure has been shown in many studies, there is limited data on accelerated rTMS protocol in which the number of daily sessions is increased. In this study, we aimed to evaluate the efficacy of accelerated rTMS treatment on depression symptoms in patients diagnosed with PSD and whose depressive symptoms persist despite medical treatment, by comparing it with sham stimulation.

Question 1: Is accelerated rTMS an effective and reliable method in the treatment of post-stroke depression? Question 2: Is accelerated rTMS effective on quality of life, functional assessment and motor recovery in patients with post-stroke depression?

Detailed description: Objective: Depression is a complication that negatively affects the quality of life and functional recovery of stroke patients and is associated with increased physical disability, cognitive and social impairment. In addition to being resistant to pharmacotherapy, the side-effect profile of the drugs used in the treatment and the increase in stroke recurrence, increase the need for new alternatives in the treatment of post-stroke depression (PSD). Repetitive transcranial magnetic stimulation (rTMS) is one of the treatment of interest in this field. In the treatment of PSD; although the effectiveness of conventional rTMS procedure has been shown in many studies, there is limited data on accelerated rTMS protocol in which the number of daily sessions is increased. In this study, we aimed to evaluate the efficacy of accelerated rTMS treatment on depression symptoms in patients diagnosed with PSD and whose depressive symptoms persist despite medical treatment, by comparing it with sham stimulation.

Eligibility criteria: Inclusion Criteria:

* Ischemic stroke in only one hemisphere is diagnosed by MRI,
* Ischemic stroke within 1-6 months,
* Diagnosis of major depression according to DSM-5 diagnostic criteria by a psychiatrist during post-stroke evaluations,
* Hamilton Depression Rating Scale (HAMD) score of ≥8 as assessed by a clinical psychologist, despite receiving at least one antidepressant treatment,
* Drug use should be stable for at least 2 weeks before accelerated rTMS treatment for depression treatment and no change in drug dose should be made for 6 weeks following treatment,
* Mini mental test score ≥ 24

Exclusion Criteria:

* Known history of epilepsy, dementia, cognitive impairment, neurodegenerative disease,
* İntracranial metallic implant (cochlear implant, brain pacemaker, drug pump, etc.),
* Lesions in the brain due to vascular, traumatic, tumoral or infectious reasons,
* Recurrent strokes,
* Aphasia,
* Alcoholism,
* Pregnancy,
* Cardiac pacemaker,
* Patients diagnosed with psychiatric diseases other than depression

Primary outcomes:
measure: Hamilton Depression Rating Scale (HAMD)
timeFrame: The depression severity of the patients was recorded by the clinical psychologist before the treatment, at the end of the treatment and 4 weeks after the end of the treatment.
Secondary outcomes:
measure: Stroke Impact Scale 3.0 (SIS)
timeFrame: Stroke Impact Scale 3.0 was evaluated by the experimenter applying rTMS before the treatment, at the end of treatment and 4 weeks after the end of treatment.
measure: Brunnstrom Stages
timeFrame: Brunnstrom Stages was evaluated by the experimenter applying rTMS before treatment, at the end of treatment and 4 weeks after the end of treatment.
measure: Functional Independence Measure (FIM)
timeFrame: Functional Independence Measure was evaluated by the experimenter applying rTMS before treatment, at the end of treatment and 4 weeks after the end of treatment.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
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