NCT06214377Completed
Transcranial Direct Current Stimulation for Treating Parkinson´s Disease-related Pain in OFF State
Effects of Transcranial Direct Current Stimulation (tDCS) on Pain Modulation in Individuals With Parkinson's Disease in the Off State
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 29 Nov 2023
- Start date
- 1 Jul 2023
- Primary completion date
- 15 Mar 2024
- Lead sponsor
- Universidad Francisco de Vitoria
- Diseases
- Parkinson disease
- NCT number
- NCT06214377
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 1 Jul 2023 to the primary completion date, 15 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of implants or metal pieces in the head.
Other illness
- Neurologic disease different from PD.
- Presence of cardiac pacemaker, vagal, brain or transcutaneous stimulators, medication pumps, ventriculoperitoneal shunts or aneurysm clips.
- History of alcohol or drugs abuse.
- Epilepsy
Other
- Pain non-related to PD.
- Dermatologic problems, wounds, or ulcers in the electrode's application area.
- Significative difficulties in language.
- Non-controlled medical problems.
- Pregnancy.
Who the study is looking for
- Diagnosis of Idiopathic Parkinson´s Disease.
- Presence of Parkinson´s Disease-related pain in the off-state.
- Neuroimaging study without previous pathologies.
- Score \> 5 in transfers (bed to chair and back) item in Barthel Index.
- Score = or \> 26 in Montreal Cognitive Assessment (MoCA).
- Tolerability for the application of electrotherapy.
- Able to provide informed consent to participate in the study
- Pain intensity \>= 3 in Visual Analogue Scale or equivalent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Beata María Ana Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.