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

Not Applicable

Completed

• Conditions: Stroke, Ischemic
• Interventions: Other: Rehabilitation (modified constraint-induced movement therapy); Other: non-invasive brain stimulation (intermittent theta-burst stimulation)

• Registration Number: NCT05308667
• Lead Sponsor: Istanbul Medeniyet University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-25
• Study First Submitted QC: 2022-03-25
• Study First Posted: 2022-04-04
• Study Start: 2022-06-02
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-04
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mCIMT group	Rehabilitation (modified constraint-induced movement therapy)	-
iTBS + mCIMT group	non-invasive brain stimulation (intermittent theta-burst stimulation)	-
iTBS + mCIMT group	Rehabilitation (modified constraint-induced movement therapy)	-
Sham iTBS+ mCIMT group	non-invasive brain stimulation (intermittent theta-burst stimulation)	-
Sham iTBS+ mCIMT group	Rehabilitation (modified constraint-induced movement therapy)	-

Primary Outcome Measures

Name	Time	Method
Wolf-Motor Function Test	45 minutes	It is a new time-based method to evaluate upper extremity performance while providing insight into joint-specific and total limb movements
Fugl-Meyer Assessment-Upper extremity	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.

Secondary Outcome Measures

Name	Time	Method
Motor Evoked Potentials (MEPs)	10 minutes	MEPs are the electrical signals recorded from the descending motor pathways or from muscles following stimulation of motor pathways within the brain.

Trial Locations

Locations (1)

Bakırköy Mazhar Osman Ruh ve Sinir Hastalıkları Hastanesi; 🇹🇷 İstanbul, Turkey