tDCS in Parkinson's Disease With Depression

NCT02315781 | Terminated

• 1 other identifier: H14-00867
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Parkinson's

Outcome Measures

Primary Outcomes (1)

• HAMD score

  an assessment of the severity of depression

  12 weeks

Secondary Outcomes (1)

• Dopamine levels

  12 weeks

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

active tDCS will be used on half of the study participants

Device: active tDCS

Sham tDCS

SHAM COMPARATOR

Sham tDCS will be used on half of the study participants

Device: Sham tDCS

Interventions

active tDCS DEVICE

transcranial direct current stimulation (tDCS), is a type of electrical stimulation for the brain

Active tDCS

Sham tDCS DEVICE

Sham tDCS will appear exactly the same as active tDCS, but no stimulation will be administered.

Sham tDCS

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• are taking a non-SSRI antidepressant medication,
• are pregnant (women of childbearing age only).
• unable to tolerate staying off anti-parkinsonian medication for 12-18 hours pre-PET scan,
• have a history of radiation therapy treatment or other high amounts of radiation.
• Artificial heart valve;

Sponsors & Collaborators

• Pacific Parkinson's Research Centre: lead

Study Sites (1)

Pacific Parkinson's Research Centre

Vancouver, British Columbia, V6T 2B5, Canada

Location

MeSH Terms

Conditions

Depression; Parkinson Disease

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• A.J Stoessl, MD

  Pacific Parkinson's Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director of the Centre for Brain Health UBC

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 12, 2014
• Study Start: January 1, 2015
• Primary Completion: December 6, 2017
• Study Completion: December 6, 2017
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

CA (1)