Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation

Depression Clinical Trial

Official title:

Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03074812
• Other study ID #: IRB00087957
• Status: Recruiting
• Phase: N/A
• Start date: February 2016
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: Yousef Salimpour, Ph.D.
• Phone: 410-502-2666
• Email: ysalimp1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of transcranial direct current stimulation (tDCS) on non-motor symptoms of Parkinson's disease, including depression and cognitive symptoms. Participants are randomized to receive active or sham tDCS for 30 minutes over 10 treatment sessions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Abel to provide written informed consent is obtained in the English language
• Age 18 to 95 years old
• Movement Disorder Society Clinical Diagnostic Criteria for probable idiopathic Parkinson disease
• Report disabling depressive or neuropsychiatric symptoms prior to study entry
• Capacity to understand the nature of the study;

Exclusion Criteria:

• Known structural brain disease such as a neoplasm, abscess etc.
• Pre-existing skull / scalp defects that would impede standardized electrode placement
• Current electronic or metal implants
• Diagnosis of Bipolar Disorder, Post-Traumatic Stress Disorder, a Psychotic Disorder or any other non-unipolar depressive disorder as a principal diagnosis in the 6 months prior to screening;
• Concurrent treatment with medication which may affect tDCS (benzodiazepines, anticonvulsants, dextromethorphan and pseudoephedrine)
• Endorse active suicidal ideation at enrollment or during any study visit, or have attempted suicide in the six months prior to screening;
• History of substance abuse or dependence in the 2 months prior to screening;
• Considered to be at significant risk of committing homicide;
• Unstable medical condition;
• Score less than 22 on the Montreal Cognitive Assessment (MoCA)
• Women of childbearing potential who are pregnant or are considering becoming pregnant during the length of the study;
• There has been a change in their depression or psychotherapy treatment regimen in the 2 weeks preceding screening;

Related Conditions & MeSH terms

• Depression
• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Device:
• Transcranial Direct Current Stimulation
Transcranial direct current stimulation (tDCS) is a commonly used non-invasive form of brain stimulation for studying motor functions in health and disease [36]. It involves the attachment of surface electrodes to the scalp through which very small electric currents (1 or 2mA) are applied via a current regulated device. The currents do not produce any sensation. The applied current affects excitability of underlying neural tissue.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital / Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Demonstrating improvements on Objective Rating Scales of Depression via structured interview	Primary outcome measure will be the number of participants who demonstrate remission of depressive symptoms OR improvement of 50% (i.e. response) on the Montgomery-Asberg Scale of Depression (MADRS)	1 months
Secondary	Apathy Scores as measure by a self-report scale (the Apathy Scale)	The dimensional degree of change in Apathy symptoms as assessed via the Apathy Scale, a subjective self-report tool of apathetic symptoms	1 months
Secondary	Subjective Depression Severity rated via self-report on depression inventory	Subjective severity of depression as measured via self-reported Beck Depression Inventory - II	1 months
Secondary	Subjective reactive to pleasure (i.e. improvement of anhedonia) as rated via self-report	Monitoring degree of change of hedonic-tone scores via the Snaith-Hamilton Pleasure Scale (SHAPS)	1 month
Secondary	Subjective improvement of Anxiety Symptoms via Rating Scale	The change in Parkinson Anxiety Scale (PAS) score per person and across sham v. experimental groups.	1 month
Secondary	Performance on abbreviated cognitive battery	Objective improvement on measures of attention, verbal fluency, working memory and recall by various bedside cognitive tests	1 month
Secondary	Improvement of Parkinsonian Motor Symptoms	Number of participants between arms and individual improvement of Movement Disorders Society Unified Parkinson Disease Rating Scale Part 3 (MDS-UPDRS Pt3) Score.	1 month