Parkinson's Disease Depression and tDCS

Pacific Parkinson's Research Centre1 site in 1 country3 target enrollmentJanuary 2015

ConditionsDepression Parkinson's

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Depression
Sponsor: Pacific Parkinson's Research Centre
Enrollment: 3
Locations: 1
Primary Endpoint: HAMD score
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Parkinson's disease (PD) is a progressive neurological disease that has effects on both movement and mental health. One of the most common mental health complications of PD is depression. Up to 30% of Parkinson's patients will experience depression at some point. We aim to investigate whether transcranial direct current stimulation (tDCS), a type of electrical stimulation for the brain, can improve depression in PD as well as improve motor function in PD.

Detailed Description

The purpose of this double-blind, randomized control design study is to investigate the efficacy of 15-sessions of tDCS (versus 15-sessions of sham tDCS) to treat depression in PD. We will also assess dopamine function in a smaller cohort of participants before and after their 15 sessions of tDCS by using PET scanning.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

December 6, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pacific Parkinson's Research Centre

Responsible Party

Principal Investigator

A. Jon Stoessl

Co-Director of the Centre for Brain Health UBC

Pacific Parkinson's Research Centre

Eligibility Criteria

Inclusion Criteria

•are outpatients,
•are voluntary and competent to consent to treatment,
•have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of major depressive disorder (MDD),
•have a diagnosis of PD according to the UK PD brain bank criteria,
•are 19 years of age or more,
•have a score \> 13 on the Beck Depression Inventory-II (BDI-II),
•still have depressive symptoms after 6 weeks or more of antidepressant (SSRI) medication treatment (and on a stabilized dose of at least 4 weeks),
•are able to adhere to the treatment schedule,
•are proficient in written and verbal English.

Exclusion Criteria

•have a history of substance dependence or abuse within the last 6 months,
•have a concomitant significant unstable medical illness,
•have active suicidal intent,
•have any history of seizure or medication-resistant epilepsy in the family,
•have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
•have a MINI diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary and causing greater impairment than MDD,
•have failed a course of ECT in the current episode or previous episode,
•have received tDCS or other neurostimulation therapy for any previous indication due to the potential compromise of expectancy effects,
•have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, cerebral aneurysm, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes, or developmental disorder,
•have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed,