TMS and Botulinum Toxin in Post-Stroke Upper Limb Spasticity
Post-stroke Spasticity of the Upper Limb
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - 80 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 39 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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 full 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).
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Double masked
rTMS Group
Participants received botulinum toxin-A treatment, conventional physical therapy, and repetitive transcranial magnetic stimulation (rTMS) using an inhibitory stimulation protocol.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMS Group
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.
Device: Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS)
cTBS Group
Participants received botulinum toxin-A treatment, conventional physical therapy, and continuous theta burst stimulation (cTBS) using an inhibitory stimulation protocol.
Device: Continuous Theta Burst Stimulation (cTBS)
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Change in Spasticity Assessed by Modified Ashworth Scale (MAS)
Time frame: Baseline, 1 Month, and 3 Months
The Modified Ashworth Scale (MAS) measures muscle spasticity. Scores range from 0 to 4, with higher scores indicating greater (worse) spasticity.
Secondary measures
Change in Motor Recovery Assessed by Brunnstrom Staging
Time frame: Baseline, 1 Month, and 3 Months
Motor recovery was assessed using the Brunnstrom Staging System. Scores range from Stage 1 (flaccidity) to Stage 6 (near-normal movement), with higher stages indicating better motor recovery.
Change in Upper Extremity Motor Function Assessed by Fugl-Meyer Assessment
Time frame: Baseline, 1 Month, and 3 Months
Upper extremity motor function was assessed using the Fugl-Meyer Assessment for Upper Extremity. Scores range from 0 to 66, with higher scores indicating better motor function.
Change in Upper Extremity Use Assessed by Motor Activity Log-28
Time frame: Baseline, 1 Month, and 3 Months
Upper Extremity Use in Daily Activities Assessed by the Motor Activity Log-28. The frequency and quality of upper extremity use in daily activities were assessed using the Motor Activity Log-28. Scores range from 0 to 5 for both the Amount of Use and Quality of Movement scales, with higher scores indicating more frequent use and better quality of movement of the affected upper extremity.
Change in Anxiety and Depression Levels Assessed by Hospital Anxiety and Depression Scale
Time frame: Baseline, 1 Month, and 3 Months
Depression was assessed using the Hospital Anxiety and Depression Scale-Depression. Scores range from 0 to 21, with higher scores indicating greater depressive symptoms.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Ankara Etlik City Hospital, Physical Medicine and Rehabilitation ClinicAnkara, Ankara, Turkey (Türkiye)Status unknown
Study team and timeline
- Lead sponsor
- Asya ÖZCAN KAVCI
- Study start
- Jan 20, 2025 Actual
- Primary completion
- May 26, 2026 Actual
- Study completion
- May 26, 2026 Actual
- First posted
- Jun 3, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Comparison of Clinical Outcomes Associated With Different Transcranial Magnetic Stimulation Protocols Combined With Botulinum Toxin-A Injection in Post-Stroke Upper Limb Spasticity
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026