Efficacy of Accelerated Repetitive Transcranial Magnetic Stimulation on Patients With Post-stroke Depression
NCT ID: NCT06157333
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2022-02-07
2023-07-11
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Active rTMS group
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.
The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)
The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device available in our center was used.
Sham group
Similar protocol was applied and sham rTMS treatment was given with a sham coil to the sham group.
The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)
The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device available in our center was used.
Interventions
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The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)
The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device available in our center was used.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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Hande Yakar
medical doctor
Locations
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Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Countries
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References
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Shen X, Liu M, Cheng Y, Jia C, Pan X, Gou Q, Liu X, Cao H, Zhang L. Repetitive transcranial magnetic stimulation for the treatment of post-stroke depression: A systematic review and meta-analysis of randomized controlled clinical trials. J Affect Disord. 2017 Mar 15;211:65-74. doi: 10.1016/j.jad.2016.12.058. Epub 2017 Jan 10.
Gaynes BN, Lux L, Gartlehner G, Asher G, Forman-Hoffman V, Green J, Boland E, Weber RP, Randolph C, Bann C, Coker-Schwimmer E, Viswanathan M, Lohr KN. Defining treatment-resistant depression. Depress Anxiety. 2020 Feb;37(2):134-145. doi: 10.1002/da.22968. Epub 2019 Oct 22.
Klomjai W, Katz R, Lackmy-Vallee A. Basic principles of transcranial magnetic stimulation (TMS) and repetitive TMS (rTMS). Ann Phys Rehabil Med. 2015 Sep;58(4):208-213. doi: 10.1016/j.rehab.2015.05.005. Epub 2015 Aug 28.
Horvath JC, Mathews J, Demitrack MA, Pascual-Leone A. The NeuroStar TMS device: conducting the FDA approved protocol for treatment of depression. J Vis Exp. 2010 Nov 12;(45):2345. doi: 10.3791/2345.
Liu C, Wang M, Liang X, Xue J, Zhang G. Efficacy and Safety of High-Frequency Repetitive Transcranial Magnetic Stimulation for Poststroke Depression: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2019 Oct;100(10):1964-1975. doi: 10.1016/j.apmr.2019.03.012. Epub 2019 Apr 17.
Shao D, Zhao ZN, Zhang YQ, Zhou XY, Zhao LB, Dong M, Xu FH, Xiang YJ, Luo HY. Efficacy of repetitive transcranial magnetic stimulation for post-stroke depression: a systematic review and meta-analysis of randomized clinical trials. Braz J Med Biol Res. 2021 Jan 15;54(3):e10010. doi: 10.1590/1414-431X202010010. eCollection 2021.
Frey J, Najib U, Lilly C, Adcock A. Novel TMS for Stroke and Depression (NoTSAD): Accelerated Repetitive Transcranial Magnetic Stimulation as a Safe and Effective Treatment for Post-stroke Depression. Front Neurol. 2020 Aug 11;11:788. doi: 10.3389/fneur.2020.00788. eCollection 2020.
Williams JB. A structured interview guide for the Hamilton Depression Rating Scale. Arch Gen Psychiatry. 1988 Aug;45(8):742-7. doi: 10.1001/archpsyc.1988.01800320058007.
HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
Frank E, Prien RF, Jarrett RB, Keller MB, Kupfer DJ, Lavori PW, Rush AJ, Weissman MM. Conceptualization and rationale for consensus definitions of terms in major depressive disorder. Remission, recovery, relapse, and recurrence. Arch Gen Psychiatry. 1991 Sep;48(9):851-5. doi: 10.1001/archpsyc.1991.01810330075011.
Kucukdeveci AA, Yavuzer G, Tennant A, Suldur N, Sonel B, Arasil T. Adaptation of the modified Barthel Index for use in physical medicine and rehabilitation in Turkey. Scand J Rehabil Med. 2000 Jun;32(2):87-92.
Lai SM, Studenski S, Duncan PW, Perera S. Persisting consequences of stroke measured by the Stroke Impact Scale. Stroke. 2002 Jul;33(7):1840-4. doi: 10.1161/01.str.0000019289.15440.f2.
Other Identifiers
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AnkaraCHBilkent-PMR-Dryakar
Identifier Type: -
Identifier Source: org_study_id