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

Primary Purpose

Stroke, Ischemic

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Rehabilitation (modified constraint-induced movement therapy)

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

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Bakırköy Mazhar Osman Ruh ve Sinir Hastalıkları HastanesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

iTBS + mCIMT group

Sham iTBS+ mCIMT group

mCIMT group

Arm Description

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment-Upper extremity

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and pain.

Wolf-Motor Function Test

It is a new time-based method to evaluate upper extremity performance while providing insight into joint-specific and total limb movements

Secondary Outcome Measures

Motor Evoked Potentials (MEPs)

MEPs are the electrical signals recorded from the descending motor pathways or from muscles following stimulation of motor pathways within the brain.

Full Information

NCT ID

NCT05308667

First Posted

March 25, 2022

Last Updated

July 17, 2023

Sponsor

Istanbul Medeniyet University

Collaborators

Istanbul University - Cerrahpasa (IUC)

1. Study Identification

Unique Protocol Identification Number

NCT05308667

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 2, 2022 (Actual)

Primary Completion Date

September 1, 2023 (Anticipated)

Study Completion Date

September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul Medeniyet University

Collaborators

Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Ischemic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

iTBS + mCIMT group

Arm Type

Experimental

Arm Title

Sham iTBS+ mCIMT group

Arm Type

Sham Comparator

Arm Title

mCIMT group

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Rehabilitation (modified constraint-induced movement therapy)

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Fugl-Meyer Assessment-Upper extremity

Description

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and pain.

Time Frame

30 minutes

Title

Wolf-Motor Function Test

Description

It is a new time-based method to evaluate upper extremity performance while providing insight into joint-specific and total limb movements

Time Frame

45 minutes

Secondary Outcome Measure Information:

Title

Motor Evoked Potentials (MEPs)

Description

MEPs are the electrical signals recorded from the descending motor pathways or from muscles following stimulation of motor pathways within the brain.

Time Frame

10 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Esma Nur kolbaşı, MSc

Phone

0216) 280 33 33

esmanur.kolbasi@medeniyet.edu.tr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof.

Organizational Affiliation

Marmara University

Official's Role

Study Director

Facility Information:

Facility Name

Bakırköy Mazhar Osman Ruh ve Sinir Hastalıkları Hastanesi

City

İstanbul

ZIP/Postal Code

34394

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Esma Nur KOLBAŞI

esmaa6828@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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