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

Complex Regional Pain Syndromes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215079
• Other study ID #: 10028974
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: January 2024
• Source: Ankara City Hospital Bilkent
• Contact: Hüma Bölük Senlikçi Associate Professor
• Phone: +905370630777
• Email: humaboluk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Clinical diagnosis of Complex Regional Pain Syndrome Diagnosis of ischemic stroke Exclusion Criteria: Epilepsy Pregnancy Cardiac Pacemaker, Brain pacemaker, Cochlear Implants

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Ischemic Stroke
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Device:
• 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
• Sham transcranial magnetic stimulation
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 program
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).

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Chang 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. — View Citation

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. — View Citation

Nardone 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
Primary	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.	Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
Primary	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.	Before the treatment, At the end of the treatment (1 week), Four weeks after the treatment
Secondary	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.	Before treatment (initial), at the end, four weeks after treatment

External Links

•   https://pubmed.ncbi.nlm.nih.gov/29504190/
•   https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7711855/