Efficacy of Accelerated Repetitive Transcranial Magnetic Stimulation on Patients With Post-stroke Depression

Ankara City Hospital

Status: Completed

Conditions: Post-stroke Depression

Treatments: Device: The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)

Study type: Interventional

Funder types: Other

Identifiers

NCT06157333

AnkaraCHBilkent-PMR-Dryakar

Details and patient eligibility

About

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?

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups, including a placebo group

Active rTMS group

Active Comparator group

Description:

We determined the motor threshold (MT) of the contralateral abductor pollicis brevis muscle as the target muscle by stimulating the left motor cortex. The MT was defined as the stimulus intensity required to produce motor evoked potentials of\> 50 mV peak-to-peak amplitude in five out of ten consecutive trials in the right abductor pollicis brevis. The rTMS was performed over the left F3 on the scalp according to the 10/20 electroencephalography system with an 8-shaped 70-mm coil. The protocol included high frequency (10 Hz) rTMS applied over the left DLPFC at 110% RMT for two sessions per day, over two weeks for a total of 20 sessions. In each session, a total of 2000 pulses were stimulated for 5 seconds, applied at 25-second intervals, and each rTMS session lasted 20 minutes. Patients were given the opportunity to rest for 1-3 hours in between sessions. A total of 4000 pulses were applied to the patients in one day.

Treatment:

Device: The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)

Sham group

Placebo Comparator group

Description:

Similar protocol was applied and sham rTMS treatment was given with a sham coil to the sham group.

Treatment:

Device: The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)