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

NCT ID: NCT03074812

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2026-10-31

Brief 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.

Conditions

Idiopathic Parkinson's Disease; Parkinson Disease; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sham tDCS

Sham transcranial direct current stimulation where current will be reduced to zero after standardized ramp up to 2 mA

Group Type: SHAM_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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.

Active tDCS

Transcranial direct current stimulation according to protocol maintained for 30 minutes after ramping up to 2 mA

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

tDCS; Brain Stimulation; Neuromodulation

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelly Mills, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital / Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00087957

Identifier Type: -

Identifier Source: org_study_id