Post-stroke Spasticity of the Upper LimbTMSNCT07624149
TMS AND BOTULINUM TOXIN IN POST-STROKE UPPER LIMB SPASTICITY
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) and Continuous Theta Burst Stimulation (cTBS) in people with Post-stroke Spasticity of the Upper Limb, run by Asya ÖZCAN KAVCI at 1 site in Turkey (Türkiye).
Trial summary
Post-stroke upper limb spasticity is an important condition that negatively affects motor recovery, upper limb functions, and activities of daily living. Multimodal treatment approaches are recommended in the management of spasticity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-stroke Spasticity of the Upper Limb
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS) and Continuous Theta Burst Stimulation (cTBS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2025to 26 May 2026
- 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
- Diagnosis of stroke (ischemic or hemorrhagic)
- Time since stroke onset between 3 and 24 months
- Age between 18 and 80 years
- Upper extremity motor recovery at Brunnstrom Stages 3-5
- Spasticity in the elbow, wrist, or finger flexor muscle groups of the upper extremity with a Modified Ashworth Scale (MAS) score between +1 and 3
- Receipt of botulinum toxin-A injection to the affected upper extremity within the previous week
Who cannot join
- History of epileptic seizures, epileptiform EEG findings, increased seizure risk, or use of antiepileptic medication
- Presence of implanted metallic or electronic devices (e.g., cardiac pacemaker, intrathecal baclofen pump)
- Pregnancy or lactation
- Presence of neurological disorders other than stroke
- History of cranial surgery
- Orthopedic conditions or previous orthopedic surgery limiting upper extremity movement
Show all 13Show fewer
- Severe upper extremity spasticity (MAS >3) or presence of contracture
- Uncontrolled hypertension, advanced heart failure (NYHA Class III-IV), chronic obstructive pulmonary disease (COPD), active infection, severe hepatic failure, or severe renal failure
- History of malignancy
- Severe cognitive impairment (Mini-Mental State Examination score <24)
- Severe aphasia or communication disorder that would interfere with participation in the study
- Botulinum toxin injection administered to the upper extremity in a separate treatment session within the previous 3 months
- Any change in medication type or dosage within the previous month for oral medications used in the management of spasticity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital, Physical Medicine and Rehabilitation Clinic
Ankara, Ankara, 06010
About this study
Official title: COMPARISON OF CLINICAL OUTCOMES ASSOCIATED WITH DIFFERENT TRANSCRANIAL MAGNETIC STIMULATION PROTOCOLS COMBINED WITH BOTULINUM TOXIN-A INJECTION IN POST-STROKE UPPER LIMB SPASTICITY
Post-stroke upper limb spasticity is an important condition that negatively affects motor recovery, upper limb functions, and activities of daily living. Multimodal treatment approaches are recommended in the management of spasticity. In recent years, the effects of transcranial magnetic stimulation (TMS) on upper limb functions and spasticity have been investigated. However, the clinical effects of different TMS protocols combined with botulinum toxin-A (BTX-A) treatment and which protocol may be more effective remain unclear. The aim of this observational study is to compare the clinical effects of different TMS protocols in patients with post-stroke upper limb spasticity receiving BTX-A treatment and to evaluate the most appropriate TMS protocol.
Read the detailed description
As part of the study, patients who received botulinum toxin type A (BTX-A) injections for upper extremity spasticity following stroke were evaluated using different TMS protocols. All patients received a standard conventional physical therapy program. TMS sessions were conducted using an inhibitory protocol, with a total of 10 sessions administered to the contralateral hemisphere at least 3 days per week. Clinical evaluations were performed at baseline, at 1 month, and at 3 months. Thus, the early and long-term clinical outcomes of treatment were investigated. Spasticity was assessed using the Modified Ashworth Scale (MAS), motor improvement using the Brunnstrom staging system, upper extremity motor function using the Fugl-Meyer Assessment, and upper extremity use in activities of daily living using the Motor Activity Log-28 (MAL-28). Additionally, patients' anxiety and depression levels were measured using the Hospital Anxiety and Depression Scale (HADS).
- Conditions
- Post-stroke Spasticity of the Upper Limb
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS), Continuous Theta Burst Stimulation (cTBS)
- Keywords
- transcranial magnetic stimulation, stroke, upper limb spasticity, TMS, Botulinum Toxin-A, Rehabilitation, Neurorehabilitation, rTMS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Repetitive transcranial magnetic stimulation (rTMS) was applied to the contralateral hemisphere using an inhibitory stimulation protocol. Treatment was administered in 10 sessions, at least 3 days per week, in combination with botulinum toxin-A injections and conventional physical therapy.
Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS)Device
Sham repetitive transcranial magnetic stimulation (sham rTMS) was administered using procedures designed to mimic active stimulation without delivering therapeutic magnetic stimulation. Treatment was provided in combination with botulinum toxin-A injections and conventional physical therapy.
Continuous Theta Burst Stimulation (cTBS)Device
Continuous theta burst stimulation (cTBS) was applied to the contralateral hemisphere using an inhibitory stimulation protocol. Treatment was administered in 10 sessions, at least 3 days per week, in combination with botulinum toxin-A injections and conventional physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| rTMS Group | Experimental | Participants received botulinum toxin-A treatment, conventional physical therapy, and repetitive transcranial magnetic stimulation (rTMS) using an inhibitory stimulation protocol. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Sham rTMS Group | Sham comparator | Participants received botulinum toxin-A treatment, conventional physical therapy, and sham repetitive transcranial magnetic stimulation (sham rTMS). The sham procedure was designed to mimic active stimulation without delivering therapeutic stimulation. Receives: Device: Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS) |
| cTBS Group | Experimental | Participants received botulinum toxin-A treatment, conventional physical therapy, and continuous theta burst stimulation (cTBS) using an inhibitory stimulation protocol. Receives: Device: Continuous Theta Burst Stimulation (cTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spasticity Assessed by Modified Ashworth Scale (MAS)
Spasticity severity was assessed using the Modified Ashworth Scale.
Measured: Baseline, 1 Month, and 3 Months
Secondary outcomes (4)
Change in Motor Recovery Assessed by Brunnstrom Staging
Motor recovery of the upper extremity and hand was assessed using Brunnstrom staging.
Measured: Baseline, 1 Month, and 3 Months
Change in Upper Extremity Motor Function Assessed by Fugl-Meyer Assessment
Upper extremity motor function was assessed using the Fugl-Meyer Assessment.
Measured: Baseline, 1 Month, and 3 Months
Change in Upper Extremity Use Assessed by Motor Activity Log-28
The frequency and quality of upper extremity use in daily activities were assessed using the Motor Activity Log-28.
Measured: Baseline, 1 Month, and 3 Months
Change in Anxiety and Depression Levels Assessed by Hospital Anxiety and Depression Scale
Anxiety and depression levels were assessed using the Hospital Anxiety and Depression Scale.
Measured: Baseline, 1 Month, and 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start20 Jan 2025
- Primary completion26 May 2026
- Study completion26 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke Spasticity of the Upper LimbStudies 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
- Model description
- Participants were assigned to parallel groups receiving different transcranial magnetic stimulation protocols in combination with standard treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asya ÖZCAN KAVCI
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Asya ÖZCAN KAVCI, Ankara Etlik City Hospital
- Investigators
- Damla CANKURTARAN, Associate Professor, MD, Principal investigator, Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624149
- Sponsor's protocol ID
- SBU-FTR-AOK-01
- Acronym
- TMS
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF CLINICAL OUTCOMES ASSOCIATED WITH DIFFERENT TRANSCRANIAL MAGNETIC STIMULATION PROTOCOLS COMBINED WITH BOTULINUM TOXIN-A INJECTION IN POST-STROKE UPPER LIMB SPASTICITY
- ClinicalTrials.gov ID
- NCT07624149
- Acronym / sponsor ID
- TMS / SBU-FTR-AOK-01
- Conditions
- Post-stroke Spasticity of the Upper Limb
- Keywords
- transcranial magnetic stimulation, stroke, upper limb spasticity, TMS, Botulinum Toxin-A, Rehabilitation, Neurorehabilitation, rTMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Asya ÖZCAN KAVCIOther government
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 26 May 2026 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 3 Jun 2026 (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.
Post-stroke upper limb spasticity is an important condition that negatively affects motor recovery, upper limb functions, and activities of daily living. Multimodal treatment approaches are recommended in the management of spasticity. In recent years, the effects of transcranial magnetic stimulation (TMS) on upper limb functions and spasticity have been investigated. However, the clinical effects of different TMS protocols combined with botulinum toxin-A (BTX-A) treatment and which protocol may be more effective remain unclear. The aim of this observational study is to compare the clinical effects of different TMS protocols in patients with post-stroke upper limb spasticity receiving BTX-A treatment and to evaluate the most appropriate TMS protocol.
Detailed description
As part of the study, patients who received botulinum toxin type A (BTX-A) injections for upper extremity spasticity following stroke were evaluated using different TMS protocols. All patients received a standard conventional physical therapy program. TMS sessions were conducted using an inhibitory protocol, with a total of 10 sessions administered to the contralateral hemisphere at least 3 days per week. Clinical evaluations were performed at baseline, at 1 month, and at 3 months. Thus, the early and long-term clinical outcomes of treatment were investigated. Spasticity was assessed using the Modified Ashworth Scale (MAS), motor improvement using the Brunnstrom staging system, upper extremity motor function using the Fugl-Meyer Assessment, and upper extremity use in activities of daily living using the Motor Activity Log-28 (MAL-28). Additionally, patients' anxiety and depression levels were measured using the Hospital Anxiety and Depression Scale (HADS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were assigned to parallel groups receiving different transcranial magnetic stimulation protocols in combination with standard treatment.
| Arm | Type | Receives |
|---|---|---|
| rTMS Group | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Participants received botulinum toxin-A treatment, conventional physical therapy, and repetitive transcranial magnetic stimulation (rTMS) using an inhibitory stimulation protocol. |
| Sham rTMS Group | Sham comparator | Device: Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS)Participants received botulinum toxin-A treatment, conventional physical therapy, and sham repetitive transcranial magnetic stimulation (sham rTMS). The sham procedure was designed to mimic active stimulation without delivering therapeutic stimulation. |
| cTBS Group | Experimental | Device: Continuous Theta Burst Stimulation (cTBS)Participants received botulinum toxin-A treatment, conventional physical therapy, and continuous theta burst stimulation (cTBS) using an inhibitory stimulation protocol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of stroke (ischemic or hemorrhagic)
- Time since stroke onset between 3 and 24 months
- Age between 18 and 80 years
- Upper extremity motor recovery at Brunnstrom Stages 3-5
- Spasticity in the elbow, wrist, or finger flexor muscle groups of the upper extremity with a Modified Ashworth Scale (MAS) score between +1 and 3
Key exclusion criteria (13 listed)
- History of epileptic seizures, epileptiform EEG findings, increased seizure risk, or use of antiepileptic medication
- Presence of implanted metallic or electronic devices (e.g., cardiac pacemaker, intrathecal baclofen pump)
- Pregnancy or lactation
- Presence of neurological disorders other than stroke
- History of cranial surgery
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)Repetitive transcranial magnetic stimulation (rTMS) was applied to the contralateral hemisphere using an inhibitory stimulation protocol. Treatment was administered in 10 sessions, at least 3 days per week, in combination with botulinum toxin-A injections and conventional physical therapy. | Device | rTMS Group |
| Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS)Sham repetitive transcranial magnetic stimulation (sham rTMS) was administered using procedures designed to mimic active stimulation without delivering therapeutic magnetic stimulation. Treatment was provided in combination with botulinum toxin-A injections and conventional physical therapy. | Device | Sham rTMS Group |
| Continuous Theta Burst Stimulation (cTBS)Continuous theta burst stimulation (cTBS) was applied to the contralateral hemisphere using an inhibitory stimulation protocol. Treatment was administered in 10 sessions, at least 3 days per week, in combination with botulinum toxin-A injections and conventional physical therapy. | Device | cTBS Group |
Primary outcome
Change in Spasticity Assessed by Modified Ashworth Scale (MAS)
Time frame: Baseline, 1 Month, and 3 Months
Spasticity severity was assessed using the Modified Ashworth Scale.
4 secondary outcomes
Change in Motor Recovery Assessed by Brunnstrom Staging
Time frame: Baseline, 1 Month, and 3 Months
Change in Upper Extremity Motor Function Assessed by Fugl-Meyer Assessment
Time frame: Baseline, 1 Month, and 3 Months
Change in Upper Extremity Use Assessed by Motor Activity Log-28
Time frame: Baseline, 1 Month, and 3 Months
Change in Anxiety and Depression Levels Assessed by Hospital Anxiety and Depression Scale
Time frame: Baseline, 1 Month, and 3 Months
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 3 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations.
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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.
Damla CANKURTARAN, Associate Professor, MD principal investigator
Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) and Continuous Theta Burst Stimulation (cTBS) in people with Post-stroke Spasticity of the Upper Limb, run by Asya ÖZCAN KAVCI at 1 site in Turkey (Türkiye).
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 6 inclusion and 13 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 3 Jun 2026. 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?
Change in Spasticity Assessed by Modified Ashworth Scale (MAS) (time frame: Baseline, 1 Month, and 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2026.