NCT05308667

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 2, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

March 25, 2022

Last Update Submit

May 4, 2024

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Motor Evoked Potentials (MEPs)

    10 minutes

Study Arms (3)

iTBS + mCIMT group

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

Sham iTBS+ mCIMT group

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

mCIMT group

ACTIVE COMPARATOR
Other: Rehabilitation (modified constraint-induced movement therapy)

Interventions

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.

Sham iTBS+ mCIMT groupiTBS + mCIMT groupmCIMT group
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.

Sham iTBS+ mCIMT groupiTBS + mCIMT group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First time and unilateral stroke
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırköy Mazhar Osman Ruh ve Sinir Hastalıkları Hastanesi

Istanbul, 34394, Turkey (Türkiye)

Location

Related Publications (1)

  • Kolbasi EN, Huseyinsinoglu BE, Ozdemir Z, Bayraktaroglu Z, Soysal A. Priming constraint-induced movement therapy with intermittent theta burst stimulation to enhance upper extremity recovery in patients with stroke: protocol for a randomized controlled study. Acta Neurol Belg. 2024 Jun;124(3):887-893. doi: 10.1007/s13760-024-02472-6. Epub 2024 Feb 8.

    PMID: 38329642DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof.

    Marmara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 4, 2022

Study Start

June 2, 2022

Primary Completion

September 1, 2023

Study Completion

September 15, 2023

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)