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

December 3, 2023 updated by: Hande Yakar, Ankara City Hospital Bilkent

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: 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.
Placebo Comparator: Sham group
Similar protocol was applied and sham rTMS treatment was given with a sham coil to the sham group.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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'.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Impact Scale 3.0 (SIS)
Time Frame: 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.
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).
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.
Brunnstrom Stages
Time Frame: Brunnstrom Stages was evaluated by the experimenter applying rTMS before treatment, at the end of treatment and 4 weeks after the end of treatment.
It is a test used to follow motor recovery after stroke. Movement patterns of hemiplegic patients are graded between 1-6.
Brunnstrom Stages was evaluated by the experimenter applying rTMS before treatment, at the end of treatment and 4 weeks after the end of treatment.
Functional Independence Measure (FIM)
Time Frame: 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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2022

Primary Completion (Actual)

July 11, 2023

Study Completion (Actual)

July 11, 2023

Study Registration Dates

First Submitted

November 24, 2023

First Submitted That Met QC Criteria

December 3, 2023

First Posted (Estimated)

December 5, 2023

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraCHBilkent-PMR-Dryakar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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