Post Stroke SpasticityNCT07669649
Effect of TENS on Spasticity
A study testing Transcutaneous electrical nerve stimulation (TENS) in people with Post Stroke Spasticity, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical trial is to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) is effective in reducing spasticity in adults with post-stroke spasticity. The primary research question is whether TENS can reduce the severity of spasticity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Stroke Spasticity
- What is being tested?
- Transcutaneous electrical nerve stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years
- Post-stroke wrist flexor spasticity scored as Grade 2 or 3 on the Australian Spasticity Assessment Scale (ASAS), specifically selecting patients whose passive stretch resistance (post-catch response) can be easily overcome to ensure accurate and unconfounded electrophysiological evaluation.
- At least 6 months post-stroke (chronic phase).
- Provision of voluntary, written informed consent prior to study enrollment.
Who cannot join
- Age <18 or >70 year
- Contraindications to transcutaneous electrical nerve stimulation (e.g., implanted electronic devices, history of epilepsy, or localized skin lesions preventing electrode placement)
- Concomitant wrist contracture or pain sufficient to impede clinical evaluation
- Structural abnormalities of the elbow joint obstructing median nerve stimulation
- Median nerve neuropathy or injury in the affected upper extremity.
- Non-stable dosage of antispastic medications within the 2 weeks prior to baseline
Show all 14Show fewer
- Initiation of medications affecting nerve conduction (e.g., antidepressants, anticonvulsants, anesthetics) within the past month; patients on a stable dose for >1 month remain eligible
- Botulinum toxin injection in the target spastic muscles within the preceding 3 months
- History of neurolytic procedures targeting spasticity in the affected limb.
- History of orthopedic or neurological surgery targeting spasticity in the affected limb
- Cognitive impairment severe enough to compromise adherence to study protocols
- Inability to maintain the required testing positions for the upper extremity joints (shoulder, elbow, forearm, and wrist)
- Pregnancy or breastfeeding
- Presence of active malignancy at or near the treatment area.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Izmir Katip Çelebi University
Izmir, Karabağlar, 35150
About this study
Official title: The Effect of Transcutaneous Electrical Nerve Stimulation on Spasticity: A Single-Subject Experimental Study
The purpose of this clinical trial is to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) is effective in reducing spasticity in adults with post-stroke spasticity. The primary research question is whether TENS can reduce the severity of spasticity. The effectiveness of TENS will be assessed by comparing spasticity-related outcomes measured before, during, and after the intervention. Participants will first undergo a one-hour baseline monitoring period, during which assessments will be conducted at 10-minute intervals. This will be followed by a 30-minute TENS intervention and a two-hour follow-up period, with assessments performed every 10 minutes. One participant will repeat this protocol once daily for three consecutive days, whereas the remaining three participants will undergo the procedure on a single occasion.
Read the detailed description
Post-stroke spasticity is a common consequence of upper motor neuron lesions and is characterized by increased muscle overactivity and exaggerated stretch reflex responses. It can negatively affect motor function, daily activities, and quality of life in stroke survivors.
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive and widely used rehabilitation modality that may modulate spinal and supraspinal neural mechanisms through activation of sensory afferent pathways. Although previous studies have reported potential benefits of TENS for spasticity management, findings remain inconsistent because of methodological heterogeneity, variability in stimulation parameters, and differences in individual treatment responses.
The purpose of this study is to evaluate the effects of sensory-level TENS on wrist flexor spasticity and spinal motor neuron excitability in individuals with chronic post-stroke spastic paresis. Specifically, the study will examine whether TENS influences clinical spasticity, the duration of any observed effects, the magnitude of treatment-related changes, and the reproducibility of these effects across participants.
Two complementary single-case experimental designs will be used. First, a withdrawal/reversal design (ABABA with washout periods) will be employed to evaluate the causal effects of TENS on outcome measures. Second, a nonconcurrent multiple-baseline design across participants will be used to assess the consistency of intervention effects across individuals.
TENS will be applied over the paretic wrist flexor muscles for 30 minutes using symmetrical biphasic rectangular pulses (100 Hz, 200 μs). Stimulation intensity will be adjusted to a clearly perceived sensory level without visible muscle contraction or discomfort.
The primary outcomes are clinical spasticity, assessed by muscle reaction angle during rapid passive stretch, and spinal motor neuron excitability, assessed by the Hmax/Mmax ratio obtained from flexor carpi radialis H-reflex recordings. Repeated measurements will be performed throughout the experimental phases to evaluate immediate and time-dependent changes associated with TENS application.
This study is expected to provide individual-level evidence regarding the effects and temporal characteristics of sensory-level TENS in chronic post-stroke spasticity.
- Conditions
- Post Stroke Spasticity
- Being tested
- Transcutaneous electrical nerve stimulation (TENS)
- Keywords
- Post stroke spasticity, Transcutaneous electrical nerve stimulation, Muscle reaction angle, H reflex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulation (TENS)Device
Transcutaneous electrical nerve stimulation (TENS) will be applied over the projection area of the paretic wrist flexor muscles (flexor carpi radialis) for 30 minutes. Stimulation parameters will consist of symmetrical biphasic rectangular pulses at a frequency of 100 Hz and a pulse duration of 200 μs. Stimulation intensity will be adjusted to produce a clearly perceived sensory sensation without visible muscle contraction or discomfort.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Experimental | Participants with chronic post-stroke wrist flexor spasticity will receive sensory-level transcutaneous electrical nerve stimulation (TENS) applied over the paretic wrist flexor muscles during the intervention (B) phase. TENS will be delivered for 30 minutes using a symmetrical biphasic rectangular waveform with a frequency of 100 Hz and a pulse duration of 200 μs. Stimulation intensity will be adjusted to a clearly perceived sensory level without visible muscle contraction or discomfort. During the baseline (A) phase, no intervention will be administered. Receives: Device: Transcutaneous electrical nerve stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle of Muscle Reaction
The Angle of Muscle Reaction (AMR) is defined as the joint angle at which a catch response is elicited in the wrist flexor muscles (flexor carpi radialis and flexor carpi ulnaris) during passive stretch performed at the highest achievable velocity. Higher values indicate lower spasticity.
Measured: From baseline assessment through completion of study participation (1 to 3 days, depending on the assigned experimental design).
Hmax / Mmax ratio
The Hmax/Mmax ratio is an electrophysiological measure of spinal motor neuron excitability obtained from flexor carpi radialis H-reflex recordings. Higher values indicate greater spinal motor neuron excitability.
Measured: From baseline assessment through completion of study participation (1 to 3 days, depending on the assigned experimental design).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Post Stroke SpasticityStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-case experimental research
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Korhan Barış Bayram, Izmir Katip Celebi University
- Investigators
- Korhan B Bayram, Principal investigator, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669649
- Sponsor's protocol ID
- 2026-KAE-0019
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since all necessary demographic, clinical, and outcome data will be reported and published in a manuscript as per the study methodology, IPD sharing is currently not deemed required.
Publications
Lance JW. Symposium synopsis. In: Feldman RG, Young RR, Koella WP, editors. Spasticity: Disordered Motor Control. Chicago: Year Book Medical Publishers; 1980. p. 485-494.
Chen B, Yang T, Liao Z, Sun F, Mei Z, Zhang W. Pathophysiology and Management Strategies for Post-Stroke Spasticity: An Update Review. Int J Mol Sci. 2025 Jan 5;26(1):406. doi: 10.3390/ijms26010406.
PubMed 39796261Tate RL, Perdices M. Introduction to single-case experimental designs: historical overview and basic concepts. In: Tate RL, Perdices M, editors. Single-Case Experimental Designs for Clinical Research and Neurorehabilitation Settings: Planning, Conduct, Analysis and Reporting. New York: Routledge; 2019. p. 3-20.
He J, Luo A, Yu J, Qian C, Liu D, Hou M, Ma Y. Quantitative assessment of spasticity: a narrative review of novel approaches and technologies. Front Neurol. 2023 Jul 5;14:1121323. doi: 10.3389/fneur.2023.1121323. eCollection 2023.
PubMed 37475737Childers MK, Biswas SS, Petroski G, Merveille O. Inhibitory casting decreases a vibratory inhibition index of the H-reflex in the spastic upper limb. Arch Phys Med Rehabil. 1999 Jun;80(6):714-6. doi: 10.1016/s0003-9993(99)90178-8.
PubMed 10378501Katz RT, Rovai GP, Brait C, Rymer WZ. Objective quantification of spastic hypertonia: correlation with clinical findings. Arch Phys Med Rehabil. 1992 Apr;73(4):339-47. doi: 10.1016/0003-9993(92)90007-j.
PubMed 1554307Burke D. Clinical uses of H reflexes of upper and lower limb muscles. Clin Neurophysiol Pract. 2016 Apr 7;1:9-17. doi: 10.1016/j.cnp.2016.02.003. eCollection 2016.
PubMed 30214954Gracies JM, Bayle N, Vinti M, Alkandari S, Vu P, Loche CM, Colas C. Five-step clinical assessment in spastic paresis. Eur J Phys Rehabil Med. 2010 Sep;46(3):411-21.
PubMed 20927007Love S, Gibson N, Smith N, Bear N, Blair E; Australian Cerebral Palsy Register Group. Interobserver reliability of the Australian Spasticity Assessment Scale (ASAS). Dev Med Child Neurol. 2016 Feb;58 Suppl 2:18-24. doi: 10.1111/dmcn.13000. Epub 2016 Jan 14.
PubMed 26762706Fernandez-Tenorio E, Serrano-Munoz D, Avendano-Coy J, Gomez-Soriano J. Transcutaneous electrical nerve stimulation for spasticity: A systematic review. Neurologia (Engl Ed). 2019 Sep;34(7):451-460. doi: 10.1016/j.nrl.2016.06.009. Epub 2016 Jul 26. English, Spanish.
PubMed 27474366Mahmood A, Veluswamy SK, Hombali A, Mullick A, N M, Solomon JM. Effect of Transcutaneous Electrical Nerve Stimulation on Spasticity in Adults With Stroke: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2019 Apr;100(4):751-768. doi: 10.1016/j.apmr.2018.10.016. Epub 2018 Nov 16.
PubMed 30452892Celnik P, Hummel F, Harris-Love M, Wolk R, Cohen LG. Somatosensory stimulation enhances the effects of training functional hand tasks in patients with chronic stroke. Arch Phys Med Rehabil. 2007 Nov;88(11):1369-76. doi: 10.1016/j.apmr.2007.08.001.
PubMed 17964875Levin MF, Hui-Chan CW. Relief of hemiparetic spasticity by TENS is associated with improvement in reflex and voluntary motor functions. Electroencephalogr Clin Neurophysiol. 1992 Apr;85(2):131-42. doi: 10.1016/0168-5597(92)90079-q.
PubMed 1373366Lazorthes Y, Sol JC, Sallerin B, Verdie JC. The surgical management of spasticity. Eur J Neurol. 2002 May;9 Suppl 1:35-41; dicussion 53-61. doi: 10.1046/j.1468-1331.2002.0090s1035.x.
PubMed 11918648McIntyre A, Lee T, Janzen S, Mays R, Mehta S, Teasell R. Systematic review of the effectiveness of pharmacological interventions in the treatment of spasticity of the hemiparetic lower extremity more than six months post stroke. Top Stroke Rehabil. 2012 Nov-Dec;19(6):479-90. doi: 10.1310/tsr1906-479.
PubMed 23192713
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electrical Nerve Stimulation on Spasticity: A Single-Subject Experimental Study
- ClinicalTrials.gov ID
- NCT07669649
- Acronym / sponsor ID
- 2026-KAE-0019
- Conditions
- Post Stroke Spasticity
- Keywords
- Post stroke spasticity, Transcutaneous electrical nerve stimulation, Muscle reaction angle, H reflex
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 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.
The purpose of this clinical trial is to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) is effective in reducing spasticity in adults with post-stroke spasticity. The primary research question is whether TENS can reduce the severity of spasticity. The effectiveness of TENS will be assessed by comparing spasticity-related outcomes measured before, during, and after the intervention. Participants will first undergo a one-hour baseline monitoring period, during which assessments will be conducted at 10-minute intervals. This will be followed by a 30-minute TENS intervention and a two-hour follow-up period, with assessments performed every 10 minutes. One participant will repeat this protocol once daily for three consecutive days, whereas the remaining three participants will undergo the procedure on a single occasion.
Detailed description
Post-stroke spasticity is a common consequence of upper motor neuron lesions and is characterized by increased muscle overactivity and exaggerated stretch reflex responses. It can negatively affect motor function, daily activities, and quality of life in stroke survivors.
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive and widely used rehabilitation modality that may modulate spinal and supraspinal neural mechanisms through activation of sensory afferent pathways. Although previous studies have reported potential benefits of TENS for spasticity management, findings remain inconsistent because of methodological heterogeneity, variability in stimulation parameters, and differences in individual treatment responses.
The purpose of this study is to evaluate the effects of sensory-level TENS on wrist flexor spasticity and spinal motor neuron excitability in individuals with chronic post-stroke spastic paresis. Specifically, the study will examine whether TENS influences clinical spasticity, the duration of any observed effects, the magnitude of treatment-related changes, and the reproducibility of these effects across participants.
Two complementary single-case experimental designs will be used. First, a withdrawal/reversal design (ABABA with washout periods) will be employed to evaluate the causal effects of TENS on outcome measures. Second, a nonconcurrent multiple-baseline design across participants will be used to assess the consistency of intervention effects across individuals.
TENS will be applied over the paretic wrist flexor muscles for 30 minutes using symmetrical biphasic rectangular pulses (100 Hz, 200 μs). Stimulation intensity will be adjusted to a clearly perceived sensory level without visible muscle contraction or discomfort.
The primary outcomes are clinical spasticity, assessed by muscle reaction angle during rapid passive stretch, and spinal motor neuron excitability, assessed by the Hmax/Mmax ratio obtained from flexor carpi radialis H-reflex recordings. Repeated measurements will be performed throughout the experimental phases to evaluate immediate and time-dependent changes associated with TENS application.
This study is expected to provide individual-level evidence regarding the effects and temporal characteristics of sensory-level TENS in chronic post-stroke spasticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-case experimental research
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Experimental | Device: Transcutaneous electrical nerve stimulation (TENS)Participants with chronic post-stroke wrist flexor spasticity will receive sensory-level transcutaneous electrical nerve stimulation (TENS) applied over the paretic wrist flexor muscles during the intervention (B) phase. TENS will be delivered for 30 minutes using a symmetrical biphasic rectangular waveform with a frequency of 100 Hz and a pulse duration of 200 μs. Stimulation intensity will be adjusted to a clearly perceived sensory level without visible muscle contraction or discomfort. During the baseline (A) phase, no intervention will be administered. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 70 years
- Post-stroke wrist flexor spasticity scored as Grade 2 or 3 on the Australian Spasticity Assessment Scale (ASAS), specifically selecting patients whose passive stretch resistance (post-catch response) can be easily overcome to ensure accurate and unconfounded electrophysiological evaluation.
- At least 6 months post-stroke (chronic phase).
- Provision of voluntary, written informed consent prior to study enrollment.
Key exclusion criteria (14 listed)
- Age <18 or >70 year
- Contraindications to transcutaneous electrical nerve stimulation (e.g., implanted electronic devices, history of epilepsy, or localized skin lesions preventing electrode placement)
- Concomitant wrist contracture or pain sufficient to impede clinical evaluation
- Structural abnormalities of the elbow joint obstructing median nerve stimulation
- Median nerve neuropathy or injury in the affected upper extremity.
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 |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS)Transcutaneous electrical nerve stimulation (TENS) will be applied over the projection area of the paretic wrist flexor muscles (flexor carpi radialis) for 30 minutes. Stimulation parameters will consist of symmetrical biphasic rectangular pulses at a frequency of 100 Hz and a pulse duration of 200 μs. Stimulation intensity will be adjusted to produce a clearly perceived sensory sensation without visible muscle contraction or discomfort. | Device | Transcutaneous electrical nerve stimulation (TENS) |
Primary outcome
Angle of Muscle Reaction
Time frame: From baseline assessment through completion of study participation (1 to 3 days, depending on the assigned experimental design).
The Angle of Muscle Reaction (AMR) is defined as the joint angle at which a catch response is elicited in the wrist flexor muscles (flexor carpi radialis and flexor carpi ulnaris) during passive stretch performed at the highest achievable velocity. Higher values indicate lower spasticity.
Hmax / Mmax ratio
Time frame: From baseline assessment through completion of study participation (1 to 3 days, depending on the assigned experimental design).
The Hmax/Mmax ratio is an electrophysiological measure of spinal motor neuron excitability obtained from flexor carpi radialis H-reflex recordings. Higher values indicate greater spinal motor neuron excitability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- BackgroundLance JW. Symposium synopsis. In: Feldman RG, Young RR, Koella WP, editors. Spasticity: Disordered Motor Control. Chicago: Year Book Medical Publishers; 1980. p. 485-494.
- Background: PubMed 39796261Chen B, Yang T, Liao Z, Sun F, Mei Z, Zhang W. Pathophysiology and Management Strategies for Post-Stroke Spasticity: An Update Review. Int J Mol Sci. 2025 Jan 5;26(1):406. doi: 10.3390/ijms26010406.
- BackgroundTate RL, Perdices M. Introduction to single-case experimental designs: historical overview and basic concepts. In: Tate RL, Perdices M, editors. Single-Case Experimental Designs for Clinical Research and Neurorehabilitation Settings: Planning, Conduct, Analysis and Reporting. New York: Routledge; 2019. p. 3-20.
- Background: PubMed 37475737He J, Luo A, Yu J, Qian C, Liu D, Hou M, Ma Y. Quantitative assessment of spasticity: a narrative review of novel approaches and technologies. Front Neurol. 2023 Jul 5;14:1121323. doi: 10.3389/fneur.2023.1121323. eCollection 2023.
- Background: PubMed 10378501Childers MK, Biswas SS, Petroski G, Merveille O. Inhibitory casting decreases a vibratory inhibition index of the H-reflex in the spastic upper limb. Arch Phys Med Rehabil. 1999 Jun;80(6):714-6. doi: 10.1016/s0003-9993(99)90178-8.
- Background: PubMed 1554307Katz RT, Rovai GP, Brait C, Rymer WZ. Objective quantification of spastic hypertonia: correlation with clinical findings. Arch Phys Med Rehabil. 1992 Apr;73(4):339-47. doi: 10.1016/0003-9993(92)90007-j.
- Background: PubMed 30214954Burke D. Clinical uses of H reflexes of upper and lower limb muscles. Clin Neurophysiol Pract. 2016 Apr 7;1:9-17. doi: 10.1016/j.cnp.2016.02.003. eCollection 2016.
- Background: PubMed 20927007Gracies JM, Bayle N, Vinti M, Alkandari S, Vu P, Loche CM, Colas C. Five-step clinical assessment in spastic paresis. Eur J Phys Rehabil Med. 2010 Sep;46(3):411-21.
- Background: PubMed 26762706Love S, Gibson N, Smith N, Bear N, Blair E; Australian Cerebral Palsy Register Group. Interobserver reliability of the Australian Spasticity Assessment Scale (ASAS). Dev Med Child Neurol. 2016 Feb;58 Suppl 2:18-24. doi: 10.1111/dmcn.13000. Epub 2016 Jan 14.
- Background: PubMed 27474366Fernandez-Tenorio E, Serrano-Munoz D, Avendano-Coy J, Gomez-Soriano J. Transcutaneous electrical nerve stimulation for spasticity: A systematic review. Neurologia (Engl Ed). 2019 Sep;34(7):451-460. doi: 10.1016/j.nrl.2016.06.009. Epub 2016 Jul 26. English, Spanish.
- Background: PubMed 30452892Mahmood A, Veluswamy SK, Hombali A, Mullick A, N M, Solomon JM. Effect of Transcutaneous Electrical Nerve Stimulation on Spasticity in Adults With Stroke: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2019 Apr;100(4):751-768. doi: 10.1016/j.apmr.2018.10.016. Epub 2018 Nov 16.
- Background: PubMed 17964875Celnik P, Hummel F, Harris-Love M, Wolk R, Cohen LG. Somatosensory stimulation enhances the effects of training functional hand tasks in patients with chronic stroke. Arch Phys Med Rehabil. 2007 Nov;88(11):1369-76. doi: 10.1016/j.apmr.2007.08.001.
- Individual participant dataSharing planned: No. Since all necessary demographic, clinical, and outcome data will be reported and published in a manuscript as per the study methodology, IPD sharing is currently not deemed required.
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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.
Korhan B Bayram principal investigator
Izmir Katip Celebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation (TENS) in people with Post Stroke Spasticity, run by Izmir Katip Celebi University 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 4 inclusion and 14 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: opening soon, as of the sponsor's last update on 25 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Korhan B Bayram, M.D. (+905073066695, korbay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angle of Muscle Reaction (time frame: From baseline assessment through completion of study participation (1 to 3 days, depending on the assigned experimental design).). 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 NCT07669649, which also lists 17 linked publications.
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 25 Jun 2026.