Clinical trial NCT04048265: TMS Treatment in Parkinson's Disease With Pain.
Official title: Study of rTMS in the Treatment of Early/Moderate Parkinson's Disease With Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Parkinson Disease
Pain
Keywords: TMS
Parkinson's disease
pain
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Changes in the pain caused by Parkinson's Disease as measured by Visual Analogue Scale Score.
timeFrame: Pre-treatment, post-treatment 0, 4 weeks
Secondary outcomes:
measure: Changes in the patient's parkinson's disease as measured by Unified Parkinson's Disease Rating Scale III(UPDRS III) score.
timeFrame: Pre-treatment, post-treatment 0, 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Neurology Department of Xuanwu Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital of Capital Medical University
name: Biao Chen, MD,PHD
role: STUDY_CHAIR
References: