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Completed

NCT Number: NCT05308667

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

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.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakırköy Mazhar Osman Ruh ve Sinir Hastalıkları Hastanesi

Istanbul, 34394, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitation (modified constraint-induced movement therapy)

Other

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)

Other

Intermittent theta-burst stimulation (iTBS): It is a form of repetitive transcranial magnetic stimulation and it increases the facilitation of the motor cortex.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2022
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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