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

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05308667
• Other study ID #: IstanbulMU64
• Status: Completed
• Phase: N/A
• Start date: June 2, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: May 2024
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 15, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Bakirköy Mazhar Osman Ruh ve Sinir Hastaliklari Hastanesi	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Medeniyet University	Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 minutes
Primary	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	45 minutes
Secondary	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.	10 minutes