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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05308667
Enrollment
15
Registered
2022-04-04
Start date
2022-06-02
Completion date
2023-09-15
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Ischemic

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.

Interventions

OTHERRehabilitation (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.

OTHERnon-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.

Sponsors

Istanbul University - Cerrahpasa
CollaboratorOTHER
Istanbul Medeniyet University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Wolf-Motor Function Test45 minutesIt 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 extremity30 minutesThe Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and pain.

Secondary

MeasureTime frameDescription
Motor Evoked Potentials (MEPs)10 minutesMEPs are the electrical signals recorded from the descending motor pathways or from muscles following stimulation of motor pathways within the brain.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026