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

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

Trial locations and contacts

1 site in 1 country.

About this study

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).

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

2. 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

3. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted22 Jan 2024
2. Study start15 Nov 2023
3. Primary completion15 Apr 2024 (estimated)
4. 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.