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Post-stroke DepressionNCT06157333

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

A study testing The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) in people with Post-stroke Depression, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Post-stroke Depression
What is being tested?
The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteTurkey (Türkiye)
Study dates
7 Feb 2022to 11 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 9Show fewer
  • Pregnancy,
  • Cardiac pacemaker,
  • Patients diagnosed with psychiatric diseases other than depression

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara Bilkent City Hospital

    Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Accelerated Repetitive Transcranial Magnetic Stimulation on Depression Symptoms in Patients With Subacute Ischemic Stroke

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?

Read the 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.

Being tested
The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)
Keywords
Accelerated rTMS, Repetitive Transcranial Magnetic Stimulation, Post-stroke Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device available in our center was used.

Study groups in NCT06157333
Study groupRoleWhat they receive
Active rTMS groupActive comparatorWe 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.
Receives: Device: The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)
Sham groupPlacebo comparatorSimilar protocol was applied and sham rTMS treatment was given with a sham coil to the sham group.
Receives: Device: The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hamilton Depression Rating Scale (HAMD)

    The HAMD is the most widely used clinician-administered depression assessment scale. The original version contains 17 items pertaining to symptoms of depression experienced over the past week. By adding up the ratings, 0-53 points are obtained. 0-7 points indicate no depression, 8-15 points indicate mild depression, 16-28 indicates moderate depression, and 29 and above indicates severe depression. The version consisting of 17 items was used in our study, and the patients' response to treatment was evaluated based on these scale scores. At the end of the 2-week rTMS application period; A HAMD score of '7' or below is considered 'Remission', a 50% or more decrease in the HAMD score is considered 'There is a response to treatment', and a decrease of less than 50% in the HAMD score is considered 'No response to treatment'.

    Measured: 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 (3)

  1. Stroke Impact Scale 3.0 (SIS)

    It is a scale that evaluates the quality of life in hemiplegic patients and consists of 8 subsections (strength, hand function, mobility, communication, activities of daily living, participation, emotion and memory) and 59 questions. The patient is asked to answer each question on a 5-point Likert scale, considering the last week. A score of 1 indicates that the patient could not complete the item, and a score of 5 indicates that the patient completed the item without any difficulty. While evaluating, strength (4-20), thinking-memory (7-35), mood-emotion (9-45), communication (7-35), activities of daily living (10-50), mobility (9-45). Scoring is done separately for 8 subsections: hand function (5-25), participation (8-40). Total score is between 59-295. A low score indicates low quality of life. In addition to 8 subsections, there is a visual analog scale that evaluates the perception of recovery after stroke with a score of 0-100 (0: No recovery, 100: Complete recovery).

    Measured: 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.

  2. Brunnstrom Stages

    It is a test used to follow motor recovery after stroke. Movement patterns of hemiplegic patients are graded between 1-6.

    Measured: Brunnstrom Stages was evaluated by the experimenter applying rTMS before treatment, at the end of treatment and 4 weeks after the end of treatment.

  3. Functional Independence Measure (FIM)

    The general body functions of the individual are evaluated with 6 sub-main sections under the headings of four motor (self-care, sphincter control, transfer and displacement) and two cognitive activities (communication and social cognition). Each subsection contains articles in its own category. Motor functions are evaluated in 13 items and cognitive functions in 5 items, and the scale consists of a total of 18 items. Each item is scored using a 7-point Likert scale, with the highest score being 7 and the lowest score being 1, depending on the patient's level of independence in relation to the relevant activity. 1-2 points are considered dependent, 3-5 points are considered partially dependent, and 6-7 points are considered independent. By summing the scores of 18 items, a total score between 18-126 is obtained. A score of 18 points indicates that the individual is completely dependent, while a score of 126 indicates complete independence.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2023
  2. Study start7 Feb 2022
  3. Primary completion11 Jul 2023
  4. Study completion11 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06157333
Sponsor's protocol ID
AnkaraCHBilkent-PMR-Dryakar
Status last verified
Dec 2023
First submitted
24 Nov 2023
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28092847

  • 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.

    PubMed 31638723

  • 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.

    PubMed 26319963

  • 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.

    PubMed 21189465

  • 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.

    PubMed 31002813

  • 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.

    PubMed 33470386

  • 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.

    PubMed 32849235

  • 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.

    PubMed 3395203

  • 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.

    PubMed 14399272

  • 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.

    PubMed 1929776

  • 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.

    PubMed 10853723

  • 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.

    PubMed 12105363

Questions about this trial

What is this clinical trial studying?

A study testing The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) in people with Post-stroke Depression, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Depression Rating Scale (HAMD) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06157333, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.

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