CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Dopaminergic medication +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06214377
NCT06214377N/ACompleted

Effects of Transcranial Direct Current Stimulation (tDCS) on Pain Modulation in Individuals With Parkinson's Disease in the Off State

Universidad Francisco de Vitoria·interventional·Posted Jan 19, 2024·Updated May 8, 2024

In Brief

A clinical study evaluating Active Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation, and 1 other intervention for Parkinson Disease and Pain. Completed, enrolled 15 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
202420252026
First PostedJan 19, 2024
Enrollment StartJul 1, 2023
Primary CompletionMar 15, 2024
Study CompletionApr 11, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 2.5 years ago

Interventions

Active Transcranial Direct Current Stimulationdevice

The Starstim tCS® equipment will be used, with 35 cm2 sponge electrodes. The tDCS over M1 will be performed by placing the active anode on the C3 point (10/20 EEG system) and the cathode on the contralateral supraorbital area (Fp2). Regarding the stimulated hemisphere, in cases of asymmetric pain, it will be applied to the contralateral M1, and in cases of bilateral pain, it will be applied to the M1 of the dominant hemisphere. A constant current of 2 mA (subthreshold intensity) will be applied for 20 minutes, with the first 30 seconds used as a ramp-up and the last 30 seconds as a ramp-down. Number of sessions: 1.

Sham Transcranial Direct Current Stimulationdevice

The Starstim tCS® equipment (Neuroelectrics Inc, Barcelona, Spain) will be used with 35 cm2 sponge electrodes. The tDCS sham over M1 will be performed by placing the electrodes in the same position as in the active tDCS protocol. However, the stimulator will automatically turn off after 30 seconds of stimulation, making it a reliable sham stimulation method. Therefore, subjects will feel the same tingling sensation but will not receive current for the remainder of the stimulation time.

Dopaminergic medicationdrug

After tDCS, the participant will take their regular dopaminergic medication in order to go from OFF state to ON state.