Pain Clinical Trial
— TMSPDPOfficial title:
Study of rTMS in the Treatment of Early/Moderate Parkinson's Disease With Pain.
NCT number | NCT04048265 |
Other study ID # | chen biao |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 6, 2019 |
Est. completion date | January 30, 2020 |
Verified date | May 2019 |
Source | Xuanwu Hospital, Beijing |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Transcranial magnetic stimulation (TMS) is a procedure that has been shown to improve pain in
chronic sufferers. It is a well-tolerated procedure that can be performed on an outpatient
basis. It uses a plastic covered coil that sends a magnetic pulse through the skull into the
brain and by targeting particular areas in the brain it can be used to help modulate the
perception of pain.
The study intends to use this technique to treat such a disabling symptom in patients who
suffer from Parkinson's Disease (PD). Initially the aim is to study this technique in 48
patients who are suffering from pain and have PD. These patients would require an EEG before
and after the stimulation. The stimulation would be performed over ten sessions and the
patients would be assessed by a clinician using well recognized clinical tools.
It is anticipated that there will be a meaningful improvement in pain. It is also anticipated
that TMS is a safe technique to use in patients with PD. The study will be used to help plan
a future study that compares TMS with sham technique to prove whether TMS could be an option
in the treatment of such a disabling condition.
Status | Completed |
Enrollment | 52 |
Est. completion date | January 30, 2020 |
Est. primary completion date | November 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Patients with Parkinson's disease diagnosed as "clinically confirmed" or "very likely" according to the 2015 MDS clinical diagnostic criteria; 2. Age = 18 Aged = 80 years old; 3. PD patients with pain, exclude tumors, diabetes, osteoarthritis, rheumatoid rheumatism and other diseases, the use of analgesic drugs is not effective or insignificant. 4. After treatment with anti-Parkinson's disease drug regimen, anti-anxiety and depression, sleep drugs, analgesic drugs, etc. for = 14 days, and the dosage is maintained during the treatment; 5. Ability to follow research plans and visit plans. Exclusion Criteria: 1. Secondary Parkinson's syndrome caused by vascular factors, toxins, drugs, etc., or Parkinson's superposition syndrome. 2. PD patients with persistent head tremors. 3. Dementia, simple intelligent state check (mmse) = 24 points. 4. Patients with suicidal tendencies and psychotic symptoms. 5, previously accepted dbs or damage surgery. 6. Contraindications for TMS (such as history of seizures, pregnant women, installation of pacemakers, metal inclusions in the body, intracranial hypertension, severe bleeding tendency, etc.) |
Country | Name | City | State |
---|---|---|---|
China | The Neurology Department of Xuanwu Hospital,Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in the pain caused by Parkinson's Disease as measured by Visual Analogue Scale Score. | To quantify changes of the severity of pain. | Pre-treatment, post-treatment 0, 4 weeks | |
Secondary | Changes in the patient's parkinson's disease as measured by Unified Parkinson's Disease Rating Scale III(UPDRS III) score. | To quantify changes of the severity of the motor symptoms of Parkinson's Disease. | Pre-treatment, post-treatment 0, 4 weeks |
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