Effects of Intermittent Theta Burst Stimulation in Addition to Constraint-Induced Movement Therapy in Stroke Patients

NCT ID: NCT05308667

Last Updated: 2024-05-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-02

Study Completion Date

2023-09-15

Brief Summary

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In recent studies, it has been reported that intermittent theta-burst stimulation (iTBS) provides additional benefits when applied in adjunct to the rehabilitation in all stages of stroke (acute, subacute, or chronic). In our study, it was aimed to evaluate the effectiveness of iTBS applied in addition to modified constraint-induced movement therapy (mCIMT). By doing so, we intend to increase patient adherence to neurorehabilitation and decrease the cost of rehabilitation.

Detailed Description

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Conditions

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Stroke, Ischemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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iTBS + mCIMT group

Group Type EXPERIMENTAL

Rehabilitation (modified constraint-induced movement therapy)

Intervention Type OTHER

Modified constraint-induced movement therapy (mCIMT): It is an intervention used to improve functionality and mobility in the more affected upper extremity post-stroke.

non-invasive brain stimulation (intermittent theta-burst stimulation)

Intervention Type OTHER

Intermittent theta-burst stimulation (iTBS): It is a form of repetitive transcranial magnetic stimulation and it increases the facilitation of the motor cortex.

Sham iTBS+ mCIMT group

Group Type SHAM_COMPARATOR

Rehabilitation (modified constraint-induced movement therapy)

Intervention Type OTHER

Modified constraint-induced movement therapy (mCIMT): It is an intervention used to improve functionality and mobility in the more affected upper extremity post-stroke.

non-invasive brain stimulation (intermittent theta-burst stimulation)

Intervention Type OTHER

Intermittent theta-burst stimulation (iTBS): It is a form of repetitive transcranial magnetic stimulation and it increases the facilitation of the motor cortex.

mCIMT group

Group Type ACTIVE_COMPARATOR

Rehabilitation (modified constraint-induced movement therapy)

Intervention Type OTHER

Modified constraint-induced movement therapy (mCIMT): It is an intervention used to improve functionality and mobility in the more affected upper extremity post-stroke.

Interventions

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Rehabilitation (modified constraint-induced movement therapy)

Modified constraint-induced movement therapy (mCIMT): It is an intervention used to improve functionality and mobility in the more affected upper extremity post-stroke.

Intervention Type OTHER

non-invasive brain stimulation (intermittent theta-burst stimulation)

Intermittent theta-burst stimulation (iTBS): It is a form of repetitive transcranial magnetic stimulation and it increases the facilitation of the motor cortex.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* First time and unilateral stroke
* 1-12 months after the incident
* Getting 24 points or more in Mini Mental Status Examination
* Being able to stand for 2 minutes without any help by using the upper extremity as a support tool when necessary.
* Being a low-functioning patient according to the CIMT criteria: a) At least 10 degrees of active wrist extension starting from the angle of full flexion, b) 10 degrees of extension at the metacarpophalangeal and inter-phalangeal joints of at least 2 fingers

Exclusion Criteria

* those who score more than 2.5 points on the Motor Activity Log-28 scale,
* who have severe pain in the upper extremity (5 and above on the Visual Analogue Scale) and spasticity (3 and above on the Modified Ashworth Scale), which may affect the treatment, and
* Those who do not have adequate communication skills.
* Patients who have visual problems
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role collaborator

Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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Esma Nur KOLBAŞI

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof.

Role: STUDY_DIRECTOR

Marmara University

Locations

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Bakırköy Mazhar Osman Ruh ve Sinir Hastalıkları Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Kolbasi EN, Huseyinsinoglu BE, Ozdemir Z, Bayraktaroglu Z, Soysal A. Priming constraint-induced movement therapy with intermittent theta burst stimulation to enhance upper extremity recovery in patients with stroke: protocol for a randomized controlled study. Acta Neurol Belg. 2024 Jun;124(3):887-893. doi: 10.1007/s13760-024-02472-6. Epub 2024 Feb 8.

Reference Type DERIVED
PMID: 38329642 (View on PubMed)

Other Identifiers

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IstanbulMU64

Identifier Type: -

Identifier Source: org_study_id

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