TMS Treatment in Parkinson's Disease With Pain.

NCT ID: NCT04048265

Last Updated: 2020-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-06
• Study Completion Date: 2020-01-30

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.

Conditions

Transcranial Magnetic Stimulation; Parkinson Disease; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pain in PD Arm one

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.

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Transcranial magnetic stimulation (TMS) is a non-invasive method that uses electromagnetic induction to produce electric currents in the cortex that are strong enough to depolarise neurons sufficiently to trigger action potentials. It is an outpatient based procedure that when used in conjunction with a neuro-navigation system, specific cortical areas can be targeted for greater accuracy and efficacy. In clinical studies, TMS is delivered as trains of pulses (repetitive TMS, rTMS) to prolong its effects. While the exact mechanism of TMS-induced analgesia is unknown, it is thought to regulate the activity of the complex cortical and subcortical networks involved in the processing of painful signals and possibly strengthening the endogenous descending pain modulation system

Pain in PD Arm two

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.

Group Type: SHAM_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Transcranial magnetic stimulation (TMS) is a non-invasive method that uses electromagnetic induction to produce electric currents in the cortex that are strong enough to depolarise neurons sufficiently to trigger action potentials. It is an outpatient based procedure that when used in conjunction with a neuro-navigation system, specific cortical areas can be targeted for greater accuracy and efficacy. In clinical studies, TMS is delivered as trains of pulses (repetitive TMS, rTMS) to prolong its effects. While the exact mechanism of TMS-induced analgesia is unknown, it is thought to regulate the activity of the complex cortical and subcortical networks involved in the processing of painful signals and possibly strengthening the endogenous descending pain modulation system

Interventions

Repetitive Transcranial Magnetic Stimulation

Transcranial magnetic stimulation (TMS) is a non-invasive method that uses electromagnetic induction to produce electric currents in the cortex that are strong enough to depolarise neurons sufficiently to trigger action potentials. It is an outpatient based procedure that when used in conjunction with a neuro-navigation system, specific cortical areas can be targeted for greater accuracy and efficacy. In clinical studies, TMS is delivered as trains of pulses (repetitive TMS, rTMS) to prolong its effects. While the exact mechanism of TMS-induced analgesia is unknown, it is thought to regulate the activity of the complex cortical and subcortical networks involved in the processing of painful signals and possibly strengthening the endogenous descending pain modulation system

Intervention Type: DEVICE

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Piu Chan

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Biao Chen, MD,PHD

Role: STUDY_CHAIR

Xuanwu Hospital of Capital Medical University

Locations

The Neurology Department of Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

chen biao

Identifier Type: -

Identifier Source: org_study_id