TMS Treatment in Parkinson's Disease With Pain.

NCT04048265 | Completed

• 1 other identifier: chen biao
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Keywords

TMS; Parkinson's disease; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in the patient's parkinson's disease as measured by Unified Parkinson's Disease Rating Scale III(UPDRS III) score.

  Pre-treatment, post-treatment 0, 4 weeks

Study Arms (2)

Pain in PD Arm one

EXPERIMENTAL

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.

Device: Repetitive Transcranial Magnetic Stimulation

Pain in PD Arm two

SHAM COMPARATOR

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.

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation 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 one; Pain in PD Arm two

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Parkinson's disease diagnosed as "clinically confirmed" or "very likely" according to the 2015 MDS clinical diagnostic criteria;
• Age ≥ 18 Aged ≤ 80 years old;
• PD patients with pain, exclude tumors, diabetes, osteoarthritis, rheumatoid rheumatism and other diseases, the use of analgesic drugs is not effective or insignificant.
• 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;
• Ability to follow research plans and visit plans.

You may not qualify if:

• Secondary Parkinson's syndrome caused by vascular factors, toxins, drugs, etc., or Parkinson's superposition syndrome.
• PD patients with persistent head tremors.
• Dementia, simple intelligent state check (mmse) ≤ 24 points.
• Patients with suicidal tendencies and psychotic symptoms. 5, previously accepted dbs or damage surgery.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

The Neurology Department of Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Parkinson Disease; Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Biao Chen, MD,PHD

  Xuanwu Hospital of Capital Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 7, 2019
• Study Start: May 6, 2019
• Primary Completion: November 29, 2019
• Study Completion: January 30, 2020
• Last Updated: April 15, 2020

Record last verified: 2019-05

Locations

CN (1)