StrokeNCT03839316
Effects of Bihemispheric Transcranial Direct Current Stimulation on Motor Function in Stroke Patients
A study testing tDCS in people with Stroke and Upper Extremity Paresis, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Motor impairment (impairment of movement) due to stroke is one of the leading disabilities in adults. In addition to established means of facilitating motor recovery after stroke such as physical and occupational therapy, a variety of experimental rehabilitation approaches have been tested. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Upper Extremity Paresis, Transcranial Direct Current Stimulation
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2017to 31 Mar 2019
- 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
- 18-75 years old, female or male
- Clinical evaluation consistent with hemiplegia
- First time stroke with brain computerized tomography (CT) and / or magnetic resonance imaging (MRI) findings consistent with stroke
- At least 3 months since stroke onset
- Presence of a stable medical condition
- Preserved cognitive function as determined by a mini mental state examination score of 23 and above
Who cannot join
- Presence of a sensory aphasia
- Presence of neglect syndrome
- A history of epilepsy
- Presence of a pacemaker
- Previous history of stroke
- History of previous cranial surgery
Show all 10Show fewer
- Presence of a brain tumour
- Presence of an intracranial metallic implant
- Marked hearing / visual impairment
- Presence of severe spasticity (grade 3-4 according to the modified Ashworth scale)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Faculty of Medicine,Ankara Hospital
Ankara, 06800
About this study
Official title: The Effect of Bihemispheric Transcranial Direct Current Stimulation Therapy on Upper Extremity Motor Functions in Stroke Patients
Motor impairment (impairment of movement) due to stroke is one of the leading disabilities in adults. In addition to established means of facilitating motor recovery after stroke such as physical and occupational therapy, a variety of experimental rehabilitation approaches have been tested. Although there have been significant advances in stroke rehabilitation with these techniques and treatments, research on this subject is continuing. Recent studies have focused on non-invasive brain stimulation techniques. Transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS) therapies, which are methods of non-invasive brain stimulation that may be effective on cerebral remodelling, aim to reestablish the disturbed balance between the anatomic areas of the brain seen in stroke patients.
The primary aim of this study is to evaluate the effectiveness of bihemispheric transcranial direct current stimulation (tDCS) applications on the upper extremity motor functions of patients with stroke.
Read the detailed description
Motor impairment due to ischemic and hemorrhagic stroke is one of the leading disabilities in adults. In addition to established means of facilitating motor recovery after stroke such as physical and occupational therapy, a variety of experimental rehabilitation approaches have been tested. Recent developments include noninvasive brain stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). The use of these tools is based on neurophysiologic studies demonstrating an imbalance of interhemispheric interactions which appears to interfere with the recovery process.
The model of interhemispheric imbalance provides a framework for developing hypotheses based on its 2 facets: 1) upregulating excitability of intact portions of the ipsilesional motor cortex and 2) downregulating excitability of the contralesional motor cortex to modulate its unrestrained inhibitory influence on ipsilesional regions. Studies to date have shown have shown the beneficial effects of tDCS on motor skills and motor learning.
Bihemispheric tDCS may potentiate the effects of anodal stimulation to the lesional hemisphere through additional modulation of interhemispheric interactions via cathodal stimulation to the contralesional motor cortex.
The primary aim of this prospective, randomized, sham controlled study is to evaluate the effectiveness of bihemispheric transcranial direct current stimulation (tDCS) applications on the upper extremity motor functions of patients with stroke.
- Being tested
- tDCS, sham tDCS
- Keywords
- Cortical stimulation, Motor function, Rehabilitation, Stroke
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called Conventional physiotherapy and occupational therapy
A constant current stimulator (ZMI Electronics LTD.,Taiwan,2012) will be used through 2 saline-soaked surface gel-sponge electrodes (22 cm2 active area). Real stimulation consisting of thirty minutes of 2 mA direct current with the anode placed over the ipsilesional and the cathode over the contralesional motor cortex (C3 and C4 of the international 10-20 EEG electrode system).
sham tDCSDevice
Also called Conventional physiotherapy and occupational therapy
For sham tDCS, the same electrode positions were used. The current was ramped up to 2 mA and slowly decreased over 30 seconds to ensure the typical initial tingling sensation
| Study group | Role | What they receive |
|---|---|---|
| tDCS group | Active comparator | Sixteen stroke patient receiving bihemispheric tDCS in addition to a conventional physiotherapy (PT) and occupational therapy (OT) program for five consecutive days per week for a three week period (a total of fifteen sessions).
The one hour long conventional PT sessions will include an upper extremity range of motion, strengthening and neurofacilitation exercise program. The one hour long OT sessions will include task specific exercises chosen according to the patient's functional status, including activities aimed at improving gross and fine motor function of the upper extremities.
The tDCS application will be applied at the beginning of each OT session and will be continued for a total of thirty minutes at 2 mA. Receives: Device: tDCS |
| Sham group | Sham comparator | Sixteen stroke patient receiving a conventional PT and OT program and sham tDCS for 5 consecutive days per week for a 3 week period ( a total of 15 sessions). The one hour long conventional PT and OT sessions will be the same as in the tDCS group. For sham tDCS, electrode application and positioning will be the same as the intervention group and will be applied at the beginning of each OT session as previously described. The current will initially be increased up to 2 mA, so to provide the typical initial tingling sensation, and slowly decreased over 30 seconds and consequently switched off. The electrodes will be removed after a total of thirty minutes. Receives: Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in upper extremity impairment
The Fugl-Meyer Upper Extremity (FMUE) Scale is a widely used and highly recommended stroke-specific, performance-based measure of impairment. It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. It has been extensively used as an outcome measure in rehabilitation trials and to record poststroke recovery, particularly in the USA.
The FMUE Scale comprises 33 items, each scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully. It is free, requires only household items for testing, and takes up to 30 minutes to administer.The total score ranges from 0-66 where 66. The higher the score the less the level of impairment.
Measured: Before treatment sessions begin and 1 week after fifteen treatment sessions have been completed (three weeks after the initial onset of treatment).
Secondary outcomes (2)
Change in functionality
The Functional Independence Measure (FIM) is an 18-item seven level ordinal scale of physical, psychological and social function.The tool is used to assess a patient's level of functionality as well as change in patient status in response to rehabilitation or medical intervention. 13 of the 18 items of the FIM assess motor function and provide a 'motor score', the remaining five questions assess communication and social skills and provide a 'cognitive score' . Each item is scored from 1=complete dependence of task to 7=complete independence of task. The lowest possible attainable total score is 18 and the highest possible attainable total score is 126. The higher the score the higher the level of independence. When considering the subscores, the lowest possible attainable motor score is 13 and the highest is 91. The lowest possible attainable cognitive subscore is 5 and the highest is 35.
Measured: Before treatment sessions begins and 1 week after fifteen treatment sessions have been completed (three weeks after the initial onset of treatment)
Change in motor activity
The Brunnstrom Stages of Stroke Recovery is a test that evaluates the motor development of stroke patients. In 1966, Signe Brunnstrom identified the stages of motor development observed in a large number of hemiplegic patients. In this staging, the hemiplegic upper extremity, lower extremity and hand are evaluated separately and the motor development of these three areas are staged from 1-6. The lowest stage according to this staging system is stage 1 (flask, no movement); the highest stage is stage 6 (normal motor function). Higher Brunnstrom stages indicate better motor development.
Measured: Before treatment sessions begins and 1 week after fifteen treatment sessions have been completed (three weeks after the initial onset of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Dec 2017
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- The aim of the study is to evaluate and compare the effect of tDCS plus conventional physiotherapy and occupational therapy to sham tDCS plus conventional physiotherapy and occupational therapy on upper extremity motor function in patients with subacute stroke was aimed in our study. 32 patients will be randomly assigned to one of two groups in parallel for the duration of the study: bihemispheric tDCS (n:16), or sham tDCS (n:16). In addition to a conventional physiotherapy and occupational therapy program, bihemispheric tDCS application will be applied to one group and sham tDCS applied to the second group. A constant current stimulator(ZMI Electronics Limited,Taiwan,2012) will be used for the application of tDCS. In both groups, the tDCS application will be started simultaneously with the occupational therapy session and will last for thirty minutes.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Cetinkaya Alisar, Baskent University
- Investigators
- Seyhan Sozay, MD, Study director, Baskent University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839316
- Sponsor's protocol ID
- KA15/271
- Status last verified
- Apr 2019
- First submitted
- 11 Feb 2019
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after identification (text, tables, figures and appendices) will be made available
Publications
Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
PubMed 21068427Tedesco Triccas L, Burridge JH, Hughes AM, Pickering RM, Desikan M, Rothwell JC, Verheyden G. Multiple sessions of transcranial direct current stimulation and upper extremity rehabilitation in stroke: A review and meta-analysis. Clin Neurophysiol. 2016 Jan;127(1):946-955. doi: 10.1016/j.clinph.2015.04.067. Epub 2015 May 4.
PubMed 25998205Elsner B, Kugler J, Mehrholz J. Transcranial direct current stimulation (tDCS) for upper limb rehabilitation after stroke: future directions. J Neuroeng Rehabil. 2018 Nov 15;15(1):106. doi: 10.1186/s12984-018-0459-7.
PubMed 30442158Chhatbar PY, Ramakrishnan V, Kautz S, George MS, Adams RJ, Feng W. Transcranial Direct Current Stimulation Post-Stroke Upper Extremity Motor Recovery Studies Exhibit a Dose-Response Relationship. Brain Stimul. 2016 Jan-Feb;9(1):16-26. doi: 10.1016/j.brs.2015.09.002. Epub 2015 Sep 7.
PubMed 26433609Fusco A, De Angelis D, Morone G, Maglione L, Paolucci T, Bragoni M, Venturiero V. The ABC of tDCS: Effects of Anodal, Bilateral and Cathodal Montages of Transcranial Direct Current Stimulation in Patients with Stroke-A Pilot Study. Stroke Res Treat. 2013;2013:837595. doi: 10.1155/2013/837595. Epub 2013 Jan 8.
PubMed 23365790Hall KM, Hamilton BB, Gordon WA, Zasler ND. Characteristics and comparisons of functional assessment indices: Disability rating scale, functional independence measure and functional assessment measure. Journal of Head Trauma Rehabilitation 8(2):60-74, 1993
Sullivan KJ, Tilson JK, Cen SY, Rose DK, Hershberg J, Correa A, Gallichio J, McLeod M, Moore C, Wu SS, Duncan PW. Fugl-Meyer assessment of sensorimotor function after stroke: standardized training procedure for clinical practice and clinical trials. Stroke. 2011 Feb;42(2):427-32. doi: 10.1161/STROKEAHA.110.592766. Epub 2010 Dec 16.
PubMed 21164120
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bihemispheric Transcranial Direct Current Stimulation Therapy on Upper Extremity Motor Functions in Stroke Patients
- ClinicalTrials.gov ID
- NCT03839316
- Acronym / sponsor ID
- KA15/271
- Keywords
- Cortical stimulation, Motor function, Rehabilitation, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 15 Feb 2019 (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.
Motor impairment (impairment of movement) due to stroke is one of the leading disabilities in adults. In addition to established means of facilitating motor recovery after stroke such as physical and occupational therapy, a variety of experimental rehabilitation approaches have been tested. Although there have been significant advances in stroke rehabilitation with these techniques and treatments, research on this subject is continuing. Recent studies have focused on non-invasive brain stimulation techniques. Transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS) therapies, which are methods of non-invasive brain stimulation that may be effective on cerebral remodelling, aim to reestablish the disturbed balance between the anatomic areas of the brain seen in stroke patients.
The primary aim of this study is to evaluate the effectiveness of bihemispheric transcranial direct current stimulation (tDCS) applications on the upper extremity motor functions of patients with stroke.
Detailed description
Motor impairment due to ischemic and hemorrhagic stroke is one of the leading disabilities in adults. In addition to established means of facilitating motor recovery after stroke such as physical and occupational therapy, a variety of experimental rehabilitation approaches have been tested. Recent developments include noninvasive brain stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). The use of these tools is based on neurophysiologic studies demonstrating an imbalance of interhemispheric interactions which appears to interfere with the recovery process.
The model of interhemispheric imbalance provides a framework for developing hypotheses based on its 2 facets: 1) upregulating excitability of intact portions of the ipsilesional motor cortex and 2) downregulating excitability of the contralesional motor cortex to modulate its unrestrained inhibitory influence on ipsilesional regions. Studies to date have shown have shown the beneficial effects of tDCS on motor skills and motor learning.
Bihemispheric tDCS may potentiate the effects of anodal stimulation to the lesional hemisphere through additional modulation of interhemispheric interactions via cathodal stimulation to the contralesional motor cortex.
The primary aim of this prospective, randomized, sham controlled study is to evaluate the effectiveness of bihemispheric transcranial direct current stimulation (tDCS) applications on the upper extremity motor functions of patients with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The aim of the study is to evaluate and compare the effect of tDCS plus conventional physiotherapy and occupational therapy to sham tDCS plus conventional physiotherapy and occupational therapy on upper extremity motor function in patients with subacute stroke was aimed in our study. 32 patients will be randomly assigned to one of two groups in parallel for the duration of the study: bihemispheric tDCS (n:16), or sham tDCS (n:16). In addition to a conventional physiotherapy and occupational therapy program, bihemispheric tDCS application will be applied to one group and sham tDCS applied to the second group. A constant current stimulator(ZMI Electronics Limited,Taiwan,2012) will be used for the application of tDCS. In both groups, the tDCS application will be started simultaneously with the occupational therapy session and will last for thirty minutes.
| Arm | Type | Receives |
|---|---|---|
| tDCS group | Active comparator | Device: tDCSSixteen stroke patient receiving bihemispheric tDCS in addition to a conventional physiotherapy (PT) and occupational therapy (OT) program for five consecutive days per week for a three week period (a total of fifteen sessions). The one hour long conventional PT sessions will include an upper extremity range of motion, strengthening and neurofacilitation exercise program. The one hour long OT sessions will include task specific exercises chosen according to the patient's functional status, including activities aimed at improving gross and fine motor function of the upper extremities. The tDCS application will be applied at the beginning of each OT session and will be continued for a total of thirty minutes at 2 mA. |
| Sham group | Sham comparator | Device: sham tDCSSixteen stroke patient receiving a conventional PT and OT program and sham tDCS for 5 consecutive days per week for a 3 week period ( a total of 15 sessions). The one hour long conventional PT and OT sessions will be the same as in the tDCS group. For sham tDCS, electrode application and positioning will be the same as the intervention group and will be applied at the beginning of each OT session as previously described. The current will initially be increased up to 2 mA, so to provide the typical initial tingling sensation, and slowly decreased over 30 seconds and consequently switched off. The electrodes will be removed after a total of thirty minutes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-75 years old, female or male
- Clinical evaluation consistent with hemiplegia
- First time stroke with brain computerized tomography (CT) and / or magnetic resonance imaging (MRI) findings consistent with stroke
- At least 3 months since stroke onset
- Presence of a stable medical condition
Key exclusion criteria (10 listed)
- Presence of a sensory aphasia
- Presence of neglect syndrome
- A history of epilepsy
- Presence of a pacemaker
- Previous history of stroke
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 |
|---|---|---|
| tDCSAlso: Conventional physiotherapy and occupational therapyA constant current stimulator (ZMI Electronics LTD.,Taiwan,2012) will be used through 2 saline-soaked surface gel-sponge electrodes (22 cm2 active area). Real stimulation consisting of thirty minutes of 2 mA direct current with the anode placed over the ipsilesional and the cathode over the contralesional motor cortex (C3 and C4 of the international 10-20 EEG electrode system). | Device | tDCS group |
| sham tDCSAlso: Conventional physiotherapy and occupational therapyFor sham tDCS, the same electrode positions were used. The current was ramped up to 2 mA and slowly decreased over 30 seconds to ensure the typical initial tingling sensation | Device | Sham group |
Primary outcome
Change in upper extremity impairment
Time frame: Before treatment sessions begin and 1 week after fifteen treatment sessions have been completed (three weeks after the initial onset of treatment).
The Fugl-Meyer Upper Extremity (FMUE) Scale is a widely used and highly recommended stroke-specific, performance-based measure of impairment. It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. It has been extensively used as an outcome measure in rehabilitation trials and to record poststroke recovery, particularly in the USA. The FMUE Scale comprises 33 items, each scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully. It is free, requires only household items for testing, and takes up to 30 minutes to administer.The total score ranges from 0-66 where 66. The higher the score the less the level of impairment.
2 secondary outcomes
Change in functionality
Time frame: Before treatment sessions begins and 1 week after fifteen treatment sessions have been completed (three weeks after the initial onset of treatment)
Change in motor activity
Time frame: Before treatment sessions begins and 1 week after fifteen treatment sessions have been completed (three weeks after the initial onset of treatment)
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 12 Apr 2019.
- Background: PubMed 21068427Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
- Background: PubMed 25998205Tedesco Triccas L, Burridge JH, Hughes AM, Pickering RM, Desikan M, Rothwell JC, Verheyden G. Multiple sessions of transcranial direct current stimulation and upper extremity rehabilitation in stroke: A review and meta-analysis. Clin Neurophysiol. 2016 Jan;127(1):946-955. doi: 10.1016/j.clinph.2015.04.067. Epub 2015 May 4.
- Background: PubMed 30442158Elsner B, Kugler J, Mehrholz J. Transcranial direct current stimulation (tDCS) for upper limb rehabilitation after stroke: future directions. J Neuroeng Rehabil. 2018 Nov 15;15(1):106. doi: 10.1186/s12984-018-0459-7.
- Background: PubMed 26433609Chhatbar PY, Ramakrishnan V, Kautz S, George MS, Adams RJ, Feng W. Transcranial Direct Current Stimulation Post-Stroke Upper Extremity Motor Recovery Studies Exhibit a Dose-Response Relationship. Brain Stimul. 2016 Jan-Feb;9(1):16-26. doi: 10.1016/j.brs.2015.09.002. Epub 2015 Sep 7.
- Background: PubMed 23365790Fusco A, De Angelis D, Morone G, Maglione L, Paolucci T, Bragoni M, Venturiero V. The ABC of tDCS: Effects of Anodal, Bilateral and Cathodal Montages of Transcranial Direct Current Stimulation in Patients with Stroke-A Pilot Study. Stroke Res Treat. 2013;2013:837595. doi: 10.1155/2013/837595. Epub 2013 Jan 8.
- BackgroundHall KM, Hamilton BB, Gordon WA, Zasler ND. Characteristics and comparisons of functional assessment indices: Disability rating scale, functional independence measure and functional assessment measure. Journal of Head Trauma Rehabilitation 8(2):60-74, 1993
- Background: PubMed 21164120Sullivan KJ, Tilson JK, Cen SY, Rose DK, Hershberg J, Correa A, Gallichio J, McLeod M, Moore C, Wu SS, Duncan PW. Fugl-Meyer assessment of sensorimotor function after stroke: standardized training procedure for clinical practice and clinical trials. Stroke. 2011 Feb;42(2):427-32. doi: 10.1161/STROKEAHA.110.592766. Epub 2010 Dec 16.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after identification (text, tables, figures and appendices) will be made available
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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.
Seyhan Sozay, MD study director
Baskent University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Stroke and Upper Extremity Paresis, run by Baskent 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 6 inclusion and 10 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 12 Apr 2019. 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 upper extremity impairment (time frame: Before treatment sessions begin and 1 week after fifteen treatment sessions have been completed (three weeks after the initial onset of treatment).). 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 NCT03839316, which also lists 7 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 12 Apr 2019.