Spasticity, Post-StrokeNCT06889922
The Effect of Low-Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Stroke Patients
A study testing Transcranial Magnetic Stimulation in people with Spasticity, Post-Stroke, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aimed to demonstrate the effects of 1 Hz rTMS applied to the contralesional hemisphere on upper extremity spasticity, spinal excitability, and additionally on motor recovery in stroke patients in the chronic phase with clinically and electrophysiological parameters (Hmax/Mmax). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spasticity, Post-Stroke
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 30 May 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a lesion in a single hemisphere confirmed by MRI,
- At least 6 months and at most 2 years having passed since the stroke,
- Spasticity in wrist flexors and finger flexors at levels 1+, 2, or 3 according to the modified Ashworth scale,
- Being between 18-75 years old,
- Having a Mini-Mental Test score of ≥ 24,
- If using antispastic medication, no change in medication dosage in the last month.
Who cannot join
- History of epilepsy, dementia, cognitive impairment, or neurodegenerative disease,
- Having a metallic materials in the area to be stimulated (such as a cochlear implant, brain pacemaker, or drug pump),
- Alcoholism,
- Pregnancy,
- Severe and newly decompensated heart failure,
- Using medications that lower the seizure threshold.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Low-Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) on Upper Extremity Spasticity and Spinal Excitability in Patients with Chronic Ischemic Stroke
In this study, we aimed to demonstrate the effects of 1 Hz rTMS applied to the contralesional hemisphere on upper extremity spasticity, spinal excitability, and additionally on motor recovery in stroke patients in the chronic phase with clinically and electrophysiological parameters (Hmax/Mmax).
Read the detailed description
Post-stroke spasticity is a common complication that can severely impact daily living activities, causing pain and hygiene challenges for a significant number of patients. Spasticity is a clinical condition that arises as a result of abnormal or hyperexcitable spinal reflexes, and the excitability of the spinal stretch reflex is regulated through supraspinal descending pathways such as the Dorsal Reticulospinal tract, Medial Reticulospinal tract, and Vestibulospinal tract. The treatment of spasticity can be categorized into non-pharmacological, pharmacological, and surgical approaches. Pharmacological options include Baclofen, Tizanidine, Dantrolene, and Botulinum toxin injections. However, these treatments may cause side effects such as sedation, cognitive impairment, and muscle weakness. The application of Repetetive Transcranial Magnetic Stimulation (rTMS) is based on the hypothesis that neuromodulation, achieved by inhibiting the contralesional hemisphere with 1 Hz stimulation or facilitating the ipsilesional hemisphere with stimulation above 1 Hz, can normalize interhemispheric inhibition.The search for alternative effective treatments and the aim to minimize undesirable side effects have led to a significant rise in studies exploring the effects of rTMS on spasticity in recent years.
Our study is a randomized, double-blind, sham-controlled clinical trial. According to the statistical analysis 20 patients who were registered at Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital between July 2021 and May 2022 and met the study criteria were included. Patients were divided into two groups using a computer-based randomization program: a 1 Hz rTMS group (n=10) and a sham group (n=10). The researcher conducting the clinical assessments was blinded to the group assignments of the patients. Furthermore, the patients themselves were unaware of which group they had been assigned to. Active stimulation was applied to the M1 region of the non-lesional hemisphere using a 70-mm figure-eight coil, while the sham group received the same protocol with a sham coil that visually resembled the active coil. The coil was initially placed tangentially over the presumed motor cortex, and the motor hotspot was identified by applying single pulses at different positions until the lowest intensity produced a significant motor-evoked potential (MEP) in the first dorsal interosseous muscle. The resting motor threshold (rMT) was then determined as the lowest intensity to produce an MEP amplitude larger than 50 mV in more than 5 out of 10 trials. In the active treatment group, 1200 pulses at 90% of rMT were delivered to the hotspot of the first dorsal interosseous muscle in the contralesional hemisphere across 10 sessions over two weeks, while the sham group received sham stimulation. Safety protocols were followed, and both groups underwent physical therapy, including upper extremity exercises and occupational therapy, within 30 minutes after each TMS session.
Clinical evaluations were conducted three times for each patient: Baseline (before treatment), 2nd week (at the and of treatment), and 6th week.
- Conditions
- Spasticity, Post-Stroke
- Being tested
- Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation Sham
- Keywords
- Transcranial Magnetic Stimulation, Spasticity, Functional Recovery
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland Dyfed, UK), 70 mm Figure-of-eight Coil
Transcranial Magnetic Stimulation ShamDevice
Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland Dyfed, UK), 70 mm Figure-of-eight Sham Coil
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Active comparator | Patients received a total of 10 sessions active rTMS on M1 region of the non-lesional hemisphere. TMS coil was initially placed tangentially to the scalp over the presumed motor cortex area. The motor hotspot is defined as the location where the lowest stimulus intensity consistently produces a significant motor-evoked potentials (MEP) in the first dorsal interosseous muscle. Once the hotspot was identified, the resting motor threshold (rMT) was determined as the lowest single pulse TMS intensity required to produce a MEP amplitude larger than 50 mV in more than 5 out of 10 trials from the first dorsal interosseous muscle. 1200 pulses at 90% of the rMT were delivered to the hotspot of the first dorsal interosseous muscle in the contralesional hemisphere. A routine physical therapy and rehabilitation program, including range of motion exercises for the upper extremity, neurophysiological exercises, and occupational therapy, was applied to patients within 30 min after TMS sessions. Receives: Device: Transcranial Magnetic Stimulation |
| Sham rTMS | Sham comparator | Patients received a total of 10 sessions sham rTMS on M1 region of the non-lesional hemisphere. However, a sham coil was used for stimulation, thus no actual stimulation was administered to the patients. Instead, the sham coil produced a sensation resembling real stimulation, with sounds and sensations on the scalp that simulated the feeling of active stimulation. A routine physical therapy and rehabilitation program, including range of motion exercises for the upper extremity, neurophysiological exercises, and occupational therapy, was applied to patients within 30 min after TMS sessions. Receives: Device: Transcranial Magnetic Stimulation Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is an updated version of the original Ashworth Scale, designed to assess spasticity in patients with central nervous system disease. It measures the increase in muscle tone, assigning a spasticity grade on a 0-4 ordinal scale. 0: no increase in muscle tone, 1: minimal resistance at the end of the range of motion, 1+: slight increase in muscle tone less than half of the ROM, 2: increase in muscle tone through most of the ROM, 3: considerable increase in muscle tone, passive movement difficult, 4: affected parts rigid.
Measured: Baseline (before treatment), 2nd week (at the end of treatment), 6th week
Electromyography - H-reflex (Hmax/Mmax)
The H reflex is the electrophysiological analogue of the stretch reflex. An increase in the amplitude of the H reflex is an indicator of spinal excitability. The peak-to-peak amplitude of the highest H reflex obtained from the flexor carpi radialis muscle (Hmax) is expressed as the ratio of the peak-to-peak amplitude of the maximum M response (Mmax) to Hmax (Hmax/Mmax). A higher Hmax/Mmax ratio obtained from the flexor carpi radialis muscle indicates reduced voluntary motor activity and increased reflex excitability.
Measured: Baseline (before treatment), 2nd week (at the end of treatment), 6th week
Secondary outcomes (1)
Fugl-Meyer Upper Extremity Motor Assessment Scale
Fugl-Meyer Upper Extremity Motor Assessment Scale used to determine the severity of motor impairment and to evaluate the effectiveness of therapeutic interventions. The assessment is conducted in 9 different categories. These are: reflex activity, flexor synergy, extensor synergy, movements performed with a combination of flexor and extensor synergies, movements performed with minimal or without synergy, normal reflex activity (only for those who score full points on step 5), wrist, hand, coordination and speed. Scoring is determined through direct observation of the patient's performance. Each item on the scale is scored using a 3-point ordinal scale based on the ability to complete the task, where 0 indicates "cannot perform," 1 indicates "performs partially," and 2 indicates "performs fully."
Measured: Baseline (before treatment), 2nd week (at the end of treatment), 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Jul 2021
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity, Post-StrokeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serhat Özdoğan, Ankara City Hospital Bilkent
- Investigators
- Elif Yalçın, Prof, MD, Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889922
- Sponsor's protocol ID
- AnkaraCHBilkent-PMR-Ozdogan
- Status last verified
- Nov 2024
- First submitted
- 17 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) on Upper Extremity Spasticity and Spinal Excitability in Patients with Chronic Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06889922
- Acronym / sponsor ID
- AnkaraCHBilkent-PMR-Ozdogan
- Conditions
- Spasticity, Post-Stroke
- Keywords
- Transcranial Magnetic Stimulation, Spasticity, Functional Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 21 Mar 2025 (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.
In this study, we aimed to demonstrate the effects of 1 Hz rTMS applied to the contralesional hemisphere on upper extremity spasticity, spinal excitability, and additionally on motor recovery in stroke patients in the chronic phase with clinically and electrophysiological parameters (Hmax/Mmax).
Detailed description
Post-stroke spasticity is a common complication that can severely impact daily living activities, causing pain and hygiene challenges for a significant number of patients. Spasticity is a clinical condition that arises as a result of abnormal or hyperexcitable spinal reflexes, and the excitability of the spinal stretch reflex is regulated through supraspinal descending pathways such as the Dorsal Reticulospinal tract, Medial Reticulospinal tract, and Vestibulospinal tract. The treatment of spasticity can be categorized into non-pharmacological, pharmacological, and surgical approaches. Pharmacological options include Baclofen, Tizanidine, Dantrolene, and Botulinum toxin injections. However, these treatments may cause side effects such as sedation, cognitive impairment, and muscle weakness. The application of Repetetive Transcranial Magnetic Stimulation (rTMS) is based on the hypothesis that neuromodulation, achieved by inhibiting the contralesional hemisphere with 1 Hz stimulation or facilitating the ipsilesional hemisphere with stimulation above 1 Hz, can normalize interhemispheric inhibition.The search for alternative effective treatments and the aim to minimize undesirable side effects have led to a significant rise in studies exploring the effects of rTMS on spasticity in recent years.
Our study is a randomized, double-blind, sham-controlled clinical trial. According to the statistical analysis 20 patients who were registered at Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital between July 2021 and May 2022 and met the study criteria were included. Patients were divided into two groups using a computer-based randomization program: a 1 Hz rTMS group (n=10) and a sham group (n=10). The researcher conducting the clinical assessments was blinded to the group assignments of the patients. Furthermore, the patients themselves were unaware of which group they had been assigned to. Active stimulation was applied to the M1 region of the non-lesional hemisphere using a 70-mm figure-eight coil, while the sham group received the same protocol with a sham coil that visually resembled the active coil. The coil was initially placed tangentially over the presumed motor cortex, and the motor hotspot was identified by applying single pulses at different positions until the lowest intensity produced a significant motor-evoked potential (MEP) in the first dorsal interosseous muscle. The resting motor threshold (rMT) was then determined as the lowest intensity to produce an MEP amplitude larger than 50 mV in more than 5 out of 10 trials. In the active treatment group, 1200 pulses at 90% of rMT were delivered to the hotspot of the first dorsal interosseous muscle in the contralesional hemisphere across 10 sessions over two weeks, while the sham group received sham stimulation. Safety protocols were followed, and both groups underwent physical therapy, including upper extremity exercises and occupational therapy, within 30 minutes after each TMS session.
Clinical evaluations were conducted three times for each patient: Baseline (before treatment), 2nd week (at the and of treatment), and 6th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Active comparator | Device: Transcranial Magnetic StimulationPatients received a total of 10 sessions active rTMS on M1 region of the non-lesional hemisphere. TMS coil was initially placed tangentially to the scalp over the presumed motor cortex area. The motor hotspot is defined as the location where the lowest stimulus intensity consistently produces a significant motor-evoked potentials (MEP) in the first dorsal interosseous muscle. Once the hotspot was identified, the resting motor threshold (rMT) was determined as the lowest single pulse TMS intensity required to produce a MEP amplitude larger than 50 mV in more than 5 out of 10 trials from the first dorsal interosseous muscle. 1200 pulses at 90% of the rMT were delivered to the hotspot of the first dorsal interosseous muscle in the contralesional hemisphere. A routine physical therapy and rehabilitation program, including range of motion exercises for the upper extremity, neurophysiological exercises, and occupational therapy, was applied to patients within 30 min after TMS sessions. |
| Sham rTMS | Sham comparator | Device: Transcranial Magnetic Stimulation ShamPatients received a total of 10 sessions sham rTMS on M1 region of the non-lesional hemisphere. However, a sham coil was used for stimulation, thus no actual stimulation was administered to the patients. Instead, the sham coil produced a sensation resembling real stimulation, with sounds and sensations on the scalp that simulated the feeling of active stimulation. A routine physical therapy and rehabilitation program, including range of motion exercises for the upper extremity, neurophysiological exercises, and occupational therapy, was applied to patients within 30 min after TMS sessions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having a lesion in a single hemisphere confirmed by MRI,
- At least 6 months and at most 2 years having passed since the stroke,
- Spasticity in wrist flexors and finger flexors at levels 1+, 2, or 3 according to the modified Ashworth scale,
- Being between 18-75 years old,
- Having a Mini-Mental Test score of ≥ 24,
Key exclusion criteria (6 listed)
- History of epilepsy, dementia, cognitive impairment, or neurodegenerative disease,
- Having a metallic materials in the area to be stimulated (such as a cochlear implant, brain pacemaker, or drug pump),
- Alcoholism,
- Pregnancy,
- Severe and newly decompensated heart failure,
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 |
|---|---|---|
| Transcranial Magnetic StimulationMagstim Rapid2 Magnetic Stimulator (Magstim, Whitland Dyfed, UK), 70 mm Figure-of-eight Coil | Device | Active rTMS |
| Transcranial Magnetic Stimulation ShamMagstim Rapid2 Magnetic Stimulator (Magstim, Whitland Dyfed, UK), 70 mm Figure-of-eight Sham Coil | Device | Sham rTMS |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: Baseline (before treatment), 2nd week (at the end of treatment), 6th week
The Modified Ashworth Scale (MAS) is an updated version of the original Ashworth Scale, designed to assess spasticity in patients with central nervous system disease. It measures the increase in muscle tone, assigning a spasticity grade on a 0-4 ordinal scale. 0: no increase in muscle tone, 1: minimal resistance at the end of the range of motion, 1+: slight increase in muscle tone less than half of the ROM, 2: increase in muscle tone through most of the ROM, 3: considerable increase in muscle tone, passive movement difficult, 4: affected parts rigid.
Electromyography - H-reflex (Hmax/Mmax)
Time frame: Baseline (before treatment), 2nd week (at the end of treatment), 6th week
The H reflex is the electrophysiological analogue of the stretch reflex. An increase in the amplitude of the H reflex is an indicator of spinal excitability. The peak-to-peak amplitude of the highest H reflex obtained from the flexor carpi radialis muscle (Hmax) is expressed as the ratio of the peak-to-peak amplitude of the maximum M response (Mmax) to Hmax (Hmax/Mmax). A higher Hmax/Mmax ratio obtained from the flexor carpi radialis muscle indicates reduced voluntary motor activity and increased reflex excitability.
1 secondary outcome
Fugl-Meyer Upper Extremity Motor Assessment Scale
Time frame: Baseline (before treatment), 2nd week (at the end of treatment), 6th week
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 21 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Elif Yalçın, Prof, MD study chair
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Spasticity, Post-Stroke, run by Ankara City Hospital Bilkent 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 6 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 21 Mar 2025. 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?
Modified Ashworth Scale (MAS) (time frame: Baseline (before treatment), 2nd week (at the end of treatment), 6th week). 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?
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 21 Mar 2025.