Effects of Intermittent Theta Burst Stimulation in Addition to Constraint-Induced Movement Therapy in Stroke Patients
May 4, 2024 updated by: Esma Nur KOLBAŞI, Istanbul Medeniyet University
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
15
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
-
-
-
İstanbul, Turkey, 34394
- Bakırköy Mazhar Osman Ruh ve Sinir Hastalıkları Hastanesi
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: iTBS + mCIMT group
|
Modified constraint-induced movement therapy (mCIMT): It is an intervention used to improve functionality and mobility in the more affected upper extremity post-stroke.
Intermittent theta-burst stimulation (iTBS): It is a form of repetitive transcranial magnetic stimulation and it increases the facilitation of the motor cortex.
|
|
Sham Comparator: Sham iTBS+ mCIMT group
|
Modified constraint-induced movement therapy (mCIMT): It is an intervention used to improve functionality and mobility in the more affected upper extremity post-stroke.
Intermittent theta-burst stimulation (iTBS): It is a form of repetitive transcranial magnetic stimulation and it increases the facilitation of the motor cortex.
|
|
Active Comparator: mCIMT group
|
Modified constraint-induced movement therapy (mCIMT): It is an intervention used to improve functionality and mobility in the more affected upper extremity post-stroke.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Assessment-Upper extremity
Time Frame: 30 minutes
|
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and pain.
|
30 minutes
|
|
Wolf-Motor Function Test
Time Frame: 45 minutes
|
It is a new time-based method to evaluate upper extremity performance while providing insight into joint-specific and total limb movements
|
45 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor Evoked Potentials (MEPs)
Time Frame: 10 minutes
|
MEPs are the electrical signals recorded from the descending motor pathways or from muscles following stimulation of motor pathways within the brain.
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof., Marmara University
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)
June 2, 2022
Primary Completion (Actual)
September 1, 2023
Study Completion (Actual)
September 15, 2023
Study Registration Dates
First Submitted
March 25, 2022
First Submitted That Met QC Criteria
March 25, 2022
First Posted (Actual)
April 4, 2022
Study Record Updates
Last Update Posted (Actual)
May 7, 2024
Last Update Submitted That Met QC Criteria
May 4, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulMU64
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.