Enrolling by invitationNo phase

Tests brain stimulation for depression in people with Parkinson's disease

Tests mild electrical brain stimulation against sham treatment in people with Parkinson's disease and depression.

Key facts

Who runs it: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Where: Milan, ItalySee the site
Trial code: NCT06885138
Registry title: Clinical and Neurophysiological Effects of tDCS on Depression in Parkinson's Disease
Status: Enrolling by invitation
People taking part: 52 people, planned
Started: 23 Apr 2024
Expected to end: Feb 2027
Type of study: Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested: active transcranial Direct Current Stimulation
sham transcranial Direct Current Stimulation
Record updated: 20 March 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Parkinson's disease who also have depressive symptoms, to test a brain stimulation treatment (tDCS) for the depression.

Age: 35 to 75 years
Sex: Women and men can join.
Disease stage: Idiopathic Parkinson's disease (diagnosed by Movement Disorder Society criteria), without dementia (Montreal Cognitive Assessment score of 22/30 or higher), with depressive symptoms.
Earlier treatment: Medicine for movement symptoms must have been stable for at least 1 month. Treatment for depressive symptoms (with or without medicine) must have been stable for at least 3 months.

Main reasons for not taking part

A pacemaker, implanted defibrillator, electrodes in the brain, or any other implanted prosthesis
Deep Brain Stimulation treatment
Epilepsy or a history of seizures
Psychosis, or suicidal thoughts or a suicide attempt in the past 6 months
Pregnancy or breastfeeding

The registry criteria, word for word

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Who can take part

Diagnosis of idiopathic Parkinson's disease according to the clinical diagnostic criteria of the Movement Disorder Society
No dementia (Montreal Cognitive Assessment score ≥ 22/30)
Presence of depressive symptoms
Pharmacological treatment for motor symptoms stable for at least 1 month
Treatment (pharmacological/non-pharmacological) for depressive symptoms stable for at least 3 months

Who cannot take part

Patients with suicidal ideation or a suicide attempt in the six months prior to the start of the study
Concomitant treatment with medications that may affect tDCS (benzodiazepines, anticonvulsants, pseudoephedrine, dextromethorphan)
Patients with epilepsy or a history of seizures
Patients with a history of skull fracture
Patients with a history of substance dependence or abuse
Patients with a pacemaker, intracranial electrodes, implanted defibrillators, or any other type of prosthesis
Patients undergoing Deep Brain Stimulation treatment
Patients with psychosis
Pregnant/breastfeeding patients

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 35 and 75 years old?

Where in Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyNo longer taking part

About the trial

What the trial wants to find out

Parkinson's disease (PD) is the second most common neurodegenerative disorder, characterized by dopaminergic cell degeneration leading to neurophysiological alterations and a heterogeneous clinical presentation. In addition to motor symptoms, PD patients often experience non-motor symptoms, particularly neuropsychiatric manifestations such as depression, anxiety, and apathy. Depression is one of the most prevalent behavioral symptoms, affecting at least 50% of PD patients, with a higher incidence compared to the general population and other disabling conditions. Two main hypotheses explain the emergence of depressive symptoms: one considers depression a reactive response to progressive disability, while the other links it to the underlying neurobiological mechanisms of PD. Additionally, depression and anxiety frequently co-occur in PD, suggesting shared neurobiological pathways.

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Conventional pharmacological treatments only partially address affective symptoms in PD, highlighting the need for innovative non-pharmacological therapies. Transcranial direct current stimulation (tDCS) has gained attention as a potential treatment, showing promising results in improving both motor and affective symptoms in PD. While preliminary studies suggest that tDCS may significantly reduce depressive symptoms, current evidence is insufficient to establish clinical recommendations, necessitating further large-scale, randomized controlled trials.

Objectives

The primary objective of this study is to evaluate the effects of repeated tDCS sessions on depressive symptoms in PD patients. Secondary objectives include:

* Assessing the potential impact of repeated tDCS sessions on anxiety, apathy, sleep quality, and quality of life in PD patients. * Investigating the neurophysiological mechanisms underlying depression and the effects induced by tDCS.

Methodology

Eligible patients will be randomly assigned to one of two groups:

1. Experimental Group: Patients will receive repeated sessions of active tDCS (anodal stimulation). The active electrode (35 cm²) will be placed over the left dorsolateral prefrontal cortex (DLPFC), with the reference electrode (35 cm²) on the contralateral area. Stimulation intensity will be set at 2mA, and each session will last 20 minutes. 2. Control Group: Patients will receive sham tDCS sessions. Electrodes will be positioned identically to the active condition, but the current will only be applied for the first 5 seconds to prevent perception of the sham condition while ensuring no neuromodulatory effects. Each session will last 20 minutes.

Both groups will undergo tDCS sessions on days 1, 2, 3, 4, 5, 12, 19, and 26 of the study.

Assessment and Outcome Measures tDCS treatment will be administered in a hospital setting using the Newronika stimulator (CE-certified medical device). The effects on depressive symptoms and neurophysiological mechanisms will be evaluated using validated clinical scales and neurophysiological assessments at multiple time points:

* T0 (Day 1): Baseline assessment before treatment initiation. * T1 (Day 5): After one week of treatment. * T5 (Day 33): One week after completing all treatment sessions. * T6 (Day 54): One month after treatment completion.

This study aims to improve the understanding of tDCS's clinical efficacy and underlying mechanisms in managing affective symptoms in PD. The findings could support the development of evidence-based non-pharmacological interventions for PD patients.

The 2 groups in the trial

Sham tDCSSham treatment, for comparison
Patients in this group will receive sham transcranial Direct Current Stimulation (tDCS)
Treatment: sham transcranial Direct Current Stimulation
Active tDCSTreatment being tested
Patients in this group will receive active transcranial Direct Current Stimulation (tDCS) (stimulation polarity: anodal).
Treatment: active transcranial Direct Current Stimulation