Stroke, IschemicNCT05308667

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

A study testing Rehabilitation (modified constraint-induced movement therapy) and non-invasive brain stimulation (intermittent theta-burst stimulation) in people with Stroke, Ischemic, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Stroke, Ischemic
What is being tested?: Rehabilitation (modified constraint-induced movement therapy) and non-invasive brain stimulation (intermittent theta-burst stimulation)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 2 Jun 2022to 15 Sep 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Bakırköy Mazhar Osman Ruh ve Sinir Hastalıkları Hastanesi
Istanbul, 34394

Other trials in Turkey (Türkiye)

About this study

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.

Conditions: Stroke, Ischemic
Being tested: Rehabilitation (modified constraint-induced movement therapy), non-invasive brain stimulation (intermittent theta-burst stimulation)
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT05308667
Study group	Role	What they receive
iTBS + mCIMT group	Experimental	Not described Receives: Other: Rehabilitation (modified constraint-induced movement therapy); Other: non-invasive brain stimulation (intermittent theta-burst stimulation)
Sham iTBS+ mCIMT group	Sham comparator	Not described Receives: Other: Rehabilitation (modified constraint-induced movement therapy); Other: non-invasive brain stimulation (intermittent theta-burst stimulation)
mCIMT group	Active comparator	Not described Receives: Other: Rehabilitation (modified constraint-induced movement therapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 45 minutes

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jun 202215 Sep 2023

First posted4 Apr 2022
Study start2 Jun 2022
Primary completion1 Sep 2023
Study completion15 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stroke, IschemicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05308667
Sponsor's protocol ID: IstanbulMU64
Status last verified: May 2024
First submitted: 25 Mar 2022
Last updated: 7 May 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38329642

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic

All Stroke, Ischemic trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Intermittent Theta Burst Stimulation in Addition to Constraint-Induced Movement Therapy in Stroke Patients
ClinicalTrials.gov ID: NCT05308667
Acronym / sponsor ID: IstanbulMU64
Conditions: Stroke, Ischemic
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Istanbul Medeniyet UniversityUniversity, hospital or other
Collaborators: Istanbul University - Cerrahpasa
Study start: 2 Jun 2022 (actual)
Primary completion: 1 Sep 2023 (actual)
Study completion: 15 Sep 2023 (actual)
First posted: 4 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
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)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rehabilitation (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.	Other	Sham iTBS+ mCIMT group, iTBS + mCIMT group, mCIMT group
non-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.	Other	Sham iTBS+ mCIMT group, iTBS + mCIMT group

Primary outcome

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.
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

1 secondary outcome

Motor Evoked Potentials (MEPs)
Time frame: 10 minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
Derived from this study: PubMed 38329642Kolbasi 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.
Individual participant dataSharing planned: No

Related trials for Stroke, Ischemic

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof. study director

Marmara University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment-Upper extremity (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05308667, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.