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

Istanbul Medeniyet University

Status: Completed

Conditions: Stroke, Ischemic

Treatments: Other: Rehabilitation (modified constraint-induced movement therapy); Other: non-invasive brain stimulation (intermittent theta-burst stimulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT05308667

IstanbulMU64

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 3 patient groups

iTBS + mCIMT group

Experimental group

Treatment:

Other: Rehabilitation (modified constraint-induced movement therapy)

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

Sham iTBS+ mCIMT group

Sham Comparator group

Treatment:

Other: Rehabilitation (modified constraint-induced movement therapy)

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

mCIMT group

Active Comparator group

Treatment:

Other: Rehabilitation (modified constraint-induced movement therapy)