tDCS in Parkinson's Disease With Depression

Parkinson's Disease Depression and tDCS

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.

Study Overview

• Status: Terminated
• Conditions: Depression; Parkinson's
• Intervention / Treatment: Device: active tDCS; Device: Sham tDCS

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 2B5
      • Pacific Parkinson's Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. have a history of substance dependence or abuse within the last 6 months,
2. have a concomitant significant unstable medical illness,
3. have active suicidal intent,
4. have any history of seizure or medication-resistant epilepsy in the family,
5. 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
6. 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,
7. have failed a course of ECT in the current episode or previous episode,
8. have received tDCS or other neurostimulation therapy for any previous indication due to the potential compromise of expectancy effects,
9. 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,
10. 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,
11. are taking a non-SSRI antidepressant medication,
12. are pregnant (women of childbearing age only).

Exclusion Criteria for PET:

1. unable to tolerate staying off anti-parkinsonian medication for 12-18 hours pre-PET scan,
2. have a history of radiation therapy treatment or other high amounts of radiation.

Exclusion Criteria for MRI:

• Artificial heart valve;
• Brain aneurysm clip;
• Electrical stimulator for nerves or bones;
• Ear or eye implant;
• Implanted drug infusion pump;
• Coil, catheter, or filter in any blood vessel;
• Orthopedic hardware (artificial joint, plate, screws);
• Other metallic prostheses;
• Shrapnel, bullets, or other metal fragments;
• Surgery or tattoos (including tattooed eyeliner) in the last six weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active tDCS; active tDCS will be used on half of the study participants	Device: active tDCS; transcranial direct current stimulation (tDCS), is a type of electrical stimulation for the brain
Sham Comparator: Sham tDCS; Sham tDCS will be used on half of the study participants	Device: Sham tDCS; Sham tDCS will appear exactly the same as active tDCS, but no stimulation will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HAMD score	an assessment of the severity of depression	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dopamine levels	PET scanning will be used to assess dopamine levels before and after sham/active tDCS in 20 participants	12 weeks

Collaborators and Investigators

• Sponsor: Pacific Parkinson's Research Centre
• Investigators: Principal Investigator: A.J Stoessl, MD, Pacific Parkinson's Research Centre

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 6, 2017
• Study Completion (Actual): December 6, 2017

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimate): December 12, 2014

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Depression; Depressive Disorder; Parkinson Disease
• Other Study ID Numbers: H14-00867