Non-Invasive Brain Stimulation for the Treatment of Parkinson´s Disease-related Pain

Summary

Pain is an under-reported but prevalent symptom in Parkinson´s Disease (PD), impacting patients' quality of life. Both pain and PD conditions cause cortical excitability reduction, but non-invasive brain stimulation is thought to be able to counteract it, resulting also effective in chronic pain conditions. The investigators in the present project aim to evaluate the efficacy of a novel brain stimulation protocol in the management of pain in PD patients during the ON state. The investigators hypothesize that active transcranial direct current stimulation (a-tDCS) over the Primary Motor Cortex (M1) can improve clinical pain and its central processing features.

Conditions

• Parkinson Disease
• Pain

Interventions

DEVICE

Active Transcranial Direct Current Stimulation

The Starstim tDCS® stimulator will be used by an experienced physical therapist to transfer direct current by a saline-soak pair of surface sponge electrodes (35cm2). The anode electrode will be placed over C3 (EEG 10/20 system) and the cathode electrode over the contralateral supraorbital area (Fp2), in order to enhance the excitability of M1 (32). Regarding the stimulated hemisphere, contralateral M1 will be stimulated in patients with asymmetric pain and the dominant (contrary to the dominant hand determined by the Edinburgh Handedness Inventory) in patients with symmetric pain, due to the widespread changes induced by tDCS in other cortical areas, including contralateral M1. A constant current of 2 milli amps intensity (subthreshold intensity) will be applied for 20 min, with 30 seconds of ramp-up and 30 seconds of ramp-down.

DEVICE

Sham Transcranial Direct Current Stimulation

The electrodes will be placed in the same positions as for M1 stimulation, but only applying ramping active current for 30 seconds in the beginning and at the end of the procedure for a reliable blinding.

Sponsors & Collaborators

• Universidad Rey Juan Carlos

  collaborator OTHER

• Hospital Beata María Ana

  collaborator OTHER

• Universidad Francisco de Vitoria

  lead OTHER

Principal Investigators

• Juan Pablo Romero Muñoz, MD PhD · Universidad Francisco de Vitoria, Facultad de Ciencias Experimentales

• Josué Fernandez Carnero, PT PhD · Universidad Rey Juan Carlos

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-03

Primary Completion

2022-06-30

Completion

2023-01-23

Countries

• Spain

Study Locations