TMS Treatment in Parkinson's Disease With Pain. (TMSPDP)

Capital Medical University

Status: Completed

Conditions: Parkinson Disease; Transcranial Magnetic Stimulation; Pain

Treatments: Device: Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04048265

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Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

5. Contraindications for TMS (such as history of seizures, pregnant women, installation of pacemakers, metal inclusions in the body, intracranial hypertension, severe bleeding tendency, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Pain in PD Arm one

Experimental group

Description:

This arm will receive a total 5 sessions of TMS stimulation in a week. Pre and post intervention scales will be performed on week one, week 2 and week 4.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

Pain in PD Arm two

Sham Comparator group

Description:

This arm will receive a total 5 sessions of sham-TMS stimulation in a week. Pre and post intervention scales will be performed on week one, week 2 and week 4.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation