Complex Regional Pain SyndromesNCT06215079
Investigation of the Efficacy of Transcranial Magnetic Stimulation in Patients Developing Complex Regional Pain Syndrome Type 1 in the Upper Extremity During the Subacute-Chronic Period After Ischemic Stroke
A study testing The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) and conventional rehabilitation program in people with Complex Regional Pain Syndromes, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to investigate transcranial magnetic stimulation (TMS) as a treatment option in Complex Regional Pain Syndrome, disseminate it to a broader patient population, and simultaneously demonstrate its applicability in the treatment of complex regional pain syndrome using a novel frequency matching. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) and conventional rehabilitation program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Complex Regional Pain Syndrome Diagnosis of ischemic stroke
Who cannot join
- Epilepsy Pregnancy Cardiac Pacemaker, Brain pacemaker, Cochlear Implants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Ankara, 06800
Özlem Yücealp Ali Medical doctor, +905318491996, ozlem.yucealp@gmail.com
About this study
The aim of our study is to investigate transcranial magnetic stimulation (TMS) as a treatment option in Complex Regional Pain Syndrome, disseminate it to a broader patient population, and simultaneously demonstrate its applicability in the treatment of complex regional pain syndrome using a novel frequency matching.
Read the detailed description
After ischemic stroke in the subacute to chronic period, 45 patients developing complex regional pain syndrome in the upper extremity will be divided into three groups: those receiving combined rTMS with conventional rehabilitation (occupational therapy and transcutaneous electrical stimulation for pain), those receiving sham rTMS with conventional rehabilitation, and those undergoing only conventional rehabilitation. The TMS group is planned to include 15 patients, the sham group 15 patients, and the group included in the conventional rehabilitation program only will also consist of 15 patients.
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK), Sham transcranial magnetic stimulation, conventional rehabilitation program
- Keywords
- complex regional pain syndrome, transcranial magnetic stimulation, ischemic stroke
- Medical subject headings
- Complex Regional Pain Syndromes, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)Device
Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation method that modulates the cortical excitability of the targeted motor area. While single-pulse TMS is generally used to explore the functioning of the brain, repetitive TMS is employed to induce lasting changes in brain activity. High-frequency rTMS leads to an increase in excitability in the motor cortex, whereas low-frequency application results in inhibition of motor cortical excitability. Theta-burst stimulation (TBS) is a form of rTMS that can be delivered continuously (cTBS) or intermittently (iTBS), thus modulating the excitability of corticospinal neurons beneath the stimulation area to either decrease or increase. rTMS is a growing research area in pain management, proven to be a safe and well-tolerated method. Studies have shown that rTMS applied to the motor cortex is a promising treatment method for chronic pain
Sham transcranial magnetic stimulationDevice
Patients in the control group will receive sham transcranial magnetic stimulation with sham coil for 35 minutes a day, 5 sessions in total, together with conventional rehabilitation.
conventional rehabilitation programDevice
Patients will receive 5 minutes of continuous ultrasound (1MHz, 2W/cm2, 1:4)), followed by a 20-minute contrast bath, and 15 minutes of TENS (frequency: 100 Hz; pulse duration: 50-100 ms; and amplitude adjusted to avoid discomfort or muscle contraction to the patient).
| Study group | Role | What they receive |
|---|---|---|
| active transcranial magnetic stimulation in stroke patients with complex regional pain syndrome | Active comparator | The intermittent theta-burst stimulation (iTBS) intensity for patients, applied under doctor supervision for a total of 5 days over one week (from Monday to Friday), will be set at 70% of the resting motor threshold. Stimulation will consist of bursts at a frequency of 50 Hz, with 3 bursts every 10 seconds, each burst lasting 2 seconds, totaling 600 bursts. Subsequently, the resting motor threshold will be adjusted to 80%, and a total of 2000 bursts will be delivered at a frequency of 10 Hz, repeated every 30 seconds, each lasting 10 seconds. Receives: Device: The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) |
| sham transcranial magnetic stimulation in stroke patients with complex regional pain syndrome | Sham comparator | Similar protocol will be applied and sham transcranial magnetic stimulation treatment will be given with a sham coil to the sham group. Receives: Device: Sham transcranial magnetic stimulation |
| conventional rehabilitation program in stroke patients with complex regional pain syndrome | Placebo comparator | Only a conventional rehabilitation program consisting of discontinuous ultrasound, transcutaneous electrical nerve stimulation (TENS), and contrast bath, formed by 5 sessions, will be applied to this group. Receives: Device: conventional rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
A 10 cm Visual Analog Scale (VAS) has been used to objectively assess widespread body pain in patients. Participants use this scale to determine the intensity of their pain. While 0 represents no pain, 10 indicates the most severe pain experienced by the individual.
Measured: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
Brunnstrom's Hemiplegia Recovery Staging
According to Brunnstrom, the stages of recovery in patients developing paralysis due to stroke progress as follows: Stage 1, where muscles are completely flaccid; Stage 2, the emergence of muscle synergies; Stage 3, the peak of involuntary movements; Stage 4, a decrease in involuntary movements and the initiation of voluntary movements; Stage 5, the appearance of more coordinated movements; Stage 6, the disappearance of spasms and the observation of fine joint movements, approaching near-complete recovery; Stage 7, where all functions return to normal.
Measured: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
Stroke Specific Quality of Life Scale (SS-QoL)
The SS-QoL is an instrument specifically used to assess health-related QoL among individuals who experienced stroke. It has 49 items in 12 domains, varying from 49 to 245 points, with responses varying from 1 to 5 points. Higher values indicate better health-related QoL.
Measured: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
Secondary outcomes (1)
Fugl Meyer Upper Extremity Assessment
It assesses the upper extremity in three parts: shoulder-elbow-forearm (upper part of the arm), wrist, and hand, allowing for the evaluation of reflex activity, synergy patterns, and voluntary movement. The maximum score for the upper part of the arm is 36 points. Wrist assessment is scored out of 10 points, evaluating stability at different angles, joint range of motion, and complex movements. The maximum total score for upper extremity assessment using the Fugl-Meyer Assessment Scale is 66 points.
Measured: Before treatment (initial), at the end, four weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start15 Nov 2023
- Primary completion15 Apr 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain SyndromesStudies 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
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Yücealp, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215079
- Sponsor's protocol ID
- 10028974
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gaertner M, Kong JT, Scherrer KH, Foote A, Mackey S, Johnson KA. Advancing Transcranial Magnetic Stimulation Methods for Complex Regional Pain Syndrome: An Open-Label Study of Paired Theta Burst and High-Frequency Stimulation. Neuromodulation. 2018 Jun;21(4):409-416. doi: 10.1111/ner.12760. Epub 2018 Mar 4.
PubMed 29504190Chang MC, Kwak SG, Park D. The effect of rTMS in the management of pain associated with CRPS. Transl Neurosci. 2020 Sep 28;11(1):363-370. doi: 10.1515/tnsci-2020-0120. eCollection 2020.
PubMed 33335776Nardone R, Brigo F, Holler Y, Sebastianelli L, Versace V, Saltuari L, Lochner P, Trinka E. Transcranial magnetic stimulation studies in complex regional pain syndrome type I: A review. Acta Neurol Scand. 2018 Feb;137(2):158-164. doi: 10.1111/ane.12852. Epub 2017 Oct 3.
PubMed 28971481
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacy of Transcranial Magnetic Stimulation in Patients Developing Complex Regional Pain Syndrome Type 1 in the Upper Extremity During the Subacute-Chronic Period After Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06215079
- Acronym / sponsor ID
- 10028974
- Conditions
- Complex Regional Pain Syndromes
- Keywords
- complex regional pain syndrome, transcranial magnetic stimulation, ischemic stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 22 Jan 2024 (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 aim of our study is to investigate transcranial magnetic stimulation (TMS) as a treatment option in Complex Regional Pain Syndrome, disseminate it to a broader patient population, and simultaneously demonstrate its applicability in the treatment of complex regional pain syndrome using a novel frequency matching.
Detailed description
After ischemic stroke in the subacute to chronic period, 45 patients developing complex regional pain syndrome in the upper extremity will be divided into three groups: those receiving combined rTMS with conventional rehabilitation (occupational therapy and transcutaneous electrical stimulation for pain), those receiving sham rTMS with conventional rehabilitation, and those undergoing only conventional rehabilitation. The TMS group is planned to include 15 patients, the sham group 15 patients, and the group included in the conventional rehabilitation program only will also consist of 15 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active transcranial magnetic stimulation in stroke patients with complex regional pain syndrome | Active comparator | Device: The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)The intermittent theta-burst stimulation (iTBS) intensity for patients, applied under doctor supervision for a total of 5 days over one week (from Monday to Friday), will be set at 70% of the resting motor threshold. Stimulation will consist of bursts at a frequency of 50 Hz, with 3 bursts every 10 seconds, each burst lasting 2 seconds, totaling 600 bursts. Subsequently, the resting motor threshold will be adjusted to 80%, and a total of 2000 bursts will be delivered at a frequency of 10 Hz, repeated every 30 seconds, each lasting 10 seconds. |
| sham transcranial magnetic stimulation in stroke patients with complex regional pain syndrome | Sham comparator | Device: Sham transcranial magnetic stimulationSimilar protocol will be applied and sham transcranial magnetic stimulation treatment will be given with a sham coil to the sham group. |
| conventional rehabilitation program in stroke patients with complex regional pain syndrome | Placebo comparator | Device: conventional rehabilitation programOnly a conventional rehabilitation program consisting of discontinuous ultrasound, transcutaneous electrical nerve stimulation (TENS), and contrast bath, formed by 5 sessions, will be applied to this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Complex Regional Pain Syndrome Diagnosis of ischemic stroke
Key exclusion criteria (1 listed)
- Epilepsy Pregnancy Cardiac Pacemaker, Brain pacemaker, Cochlear Implants
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 |
|---|---|---|
| The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK)Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation method that modulates the cortical excitability of the targeted motor area. While single-pulse TMS is generally used to explore the functioning of the brain, repetitive TMS is employed to induce lasting changes in brain activity. High-frequency rTMS leads to an increase in excitability in the motor cortex, whereas low-frequency application results in inhibition of motor cortical excitability. Theta-burst stimulation (TBS) is a form of rTMS that can be delivered continuously (cTBS) or intermittently (iTBS), thus modulating the excitability of corticospinal neurons beneath the stimulation area to either decrease or increase. rTMS is a growing research area in pain management, proven to be a safe and well-tolerated method. Studies have shown that rTMS applied to the motor cortex is a promising treatment method for chronic pain | Device | active transcranial magnetic stimulation in stroke patients with complex regional pain syndrome |
| Sham transcranial magnetic stimulationPatients in the control group will receive sham transcranial magnetic stimulation with sham coil for 35 minutes a day, 5 sessions in total, together with conventional rehabilitation. | Device | sham transcranial magnetic stimulation in stroke patients with complex regional pain syndrome |
| conventional rehabilitation programPatients will receive 5 minutes of continuous ultrasound (1MHz, 2W/cm2, 1:4)), followed by a 20-minute contrast bath, and 15 minutes of TENS (frequency: 100 Hz; pulse duration: 50-100 ms; and amplitude adjusted to avoid discomfort or muscle contraction to the patient). | Device | conventional rehabilitation program in stroke patients with complex regional pain syndrome |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
A 10 cm Visual Analog Scale (VAS) has been used to objectively assess widespread body pain in patients. Participants use this scale to determine the intensity of their pain. While 0 represents no pain, 10 indicates the most severe pain experienced by the individual.
Brunnstrom's Hemiplegia Recovery Staging
Time frame: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
According to Brunnstrom, the stages of recovery in patients developing paralysis due to stroke progress as follows: Stage 1, where muscles are completely flaccid; Stage 2, the emergence of muscle synergies; Stage 3, the peak of involuntary movements; Stage 4, a decrease in involuntary movements and the initiation of voluntary movements; Stage 5, the appearance of more coordinated movements; Stage 6, the disappearance of spasms and the observation of fine joint movements, approaching near-complete recovery; Stage 7, where all functions return to normal.
Stroke Specific Quality of Life Scale (SS-QoL)
Time frame: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
The SS-QoL is an instrument specifically used to assess health-related QoL among individuals who experienced stroke. It has 49 items in 12 domains, varying from 49 to 245 points, with responses varying from 1 to 5 points. Higher values indicate better health-related QoL.
1 secondary outcome
Fugl Meyer Upper Extremity Assessment
Time frame: Before treatment (initial), at the end, four weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Background: PubMed 29504190Gaertner M, Kong JT, Scherrer KH, Foote A, Mackey S, Johnson KA. Advancing Transcranial Magnetic Stimulation Methods for Complex Regional Pain Syndrome: An Open-Label Study of Paired Theta Burst and High-Frequency Stimulation. Neuromodulation. 2018 Jun;21(4):409-416. doi: 10.1111/ner.12760. Epub 2018 Mar 4.
- Background: PubMed 33335776Chang MC, Kwak SG, Park D. The effect of rTMS in the management of pain associated with CRPS. Transl Neurosci. 2020 Sep 28;11(1):363-370. doi: 10.1515/tnsci-2020-0120. eCollection 2020.
- Background: PubMed 28971481Nardone R, Brigo F, Holler Y, Sebastianelli L, Versace V, Saltuari L, Lochner P, Trinka E. Transcranial magnetic stimulation studies in complex regional pain syndrome type I: A review. Acta Neurol Scand. 2018 Feb;137(2):158-164. doi: 10.1111/ane.12852. Epub 2017 Oct 3.
- https://pubmed.ncbi.nlm.nih.gov/29504190/Link provided by the sponsor.
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7711855/Link provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Magstim Rapid2 Plus Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) and conventional rehabilitation program in people with Complex Regional Pain Syndromes, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hüma Bölük Şenlikçi Associate Professor (+905370630777, humaboluk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment). The study lists 3 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 NCT06215079, which also lists 3 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 22 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.