NCT06214377

Transcranial Direct Current Stimulation for Treating Parkinson´s Disease-related Pain in OFF State

Completed NA Last updated 8 May 2024

What this trial tests

NA trial testing Active Transcranial Direct Current Stimulation in Parkinson Disease in 15 participants. Completed in 11 April 2024.

Timeline

1 July 2023

Primary endpoint
15 March 2024

11 April 2024

Quick facts

Lead sponsor	Universidad Francisco de Vitoria
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	15
Start date	1 July 2023
Primary completion	15 March 2024
Estimated completion	11 April 2024
Sites	1 location across Spain

Drugs / interventions tested

• Active Transcranial Direct Current Stimulation
• Sham Transcranial Direct Current Stimulation
• Dopaminergic medication — full drug profile →

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →
• Pain — all drugs for Pain →

Sponsor

Universidad Francisco de Vitoria — full company profile →

Who can join

18 and older, any sex, with Parkinson Disease or Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Parkinson's Disease (PD) is a neurodegenerative disorder characterized by motor and non-motor symptoms. Pain is a significant symptom in PD, affecting a large percentage of patients and impacting their quality of life. The mechanisms of pain in PD involve complex changes in pain-modulating pathways, including dopaminergic and non-dopaminergic systems.

To address the lack of pain management strategies, the investigators propose exploring non-pharmacological therapies like transcranial direct current stimulation (tDCS). tDCS is a safe and non-invasive technique that modulates neuronal activity. It has shown positive effects on pain processing in healthy individuals and chronic pain patients, but its potential for PD-associated pain remains largely unexplored.

The primary motor cortex (M1) is a target for tDCS as it is believed to influence pain processing in other brain regions involved in sensory and emotional aspects. Initial studies suggest the benefits of tDCS in PD, including enhanced motor potentials and potential modulation of dopaminergic pathways. However, there are currently no published studies specifically investigating the effects of tDCS on PD-related pain, highlighting the need for further research.

A proof-of-concept trial is proposed to examine the effects of a single tDCS session on M1 in PD patients during the OFF state (without medication) and after taking dopaminergic medication. The study aims to assess the pain-relieving effects of tDCS in PD and explore potential synergies between tDCS and dopaminergic medication. By better understanding the impact of tDCS on pain relief in PD, this research may offer insights into alternative non-pharmacological approaches for managing pain in PD.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transcranial Direct Current Stimulation in Parkinson's Disease Patients in the Off State: A Randomized Controlled Crossover Trial Examining the Effects on Pain With and Without the Influence of Dopaminergic Medication.
   González-Zamorano Y, Moreno-Verdú M, Martínez-Benito A, Fernández-Carnero J, et al · · 2025 · cited 2× · PMID 41039704 · DOI 10.1111/papr.70082
2. FOXO family and neurodegenerative diseases: Mechanisms of action and therapeutic potential.
   Lv Z, Liu X, Zhou Z, Huang Q, et al · · 2026 · PMID 42202637 · DOI 10.1016/j.redox.2026.104218