tDCS in Parkinson's Disease With Depression
Primary Purpose
Depression, Parkinson's
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
active tDCS
Sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Depression
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,
- are taking a non-SSRI antidepressant medication,
- are pregnant (women of childbearing age only).
Exclusion Criteria for PET:
- 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.
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.
Sites / Locations
- Pacific Parkinson's Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active tDCS
Sham tDCS
Arm Description
active tDCS will be used on half of the study participants
Sham tDCS will be used on half of the study participants
Outcomes
Primary Outcome Measures
HAMD score
an assessment of the severity of depression
Secondary Outcome Measures
Dopamine levels
PET scanning will be used to assess dopamine levels before and after sham/active tDCS in 20 participants
Full Information
NCT ID
NCT02315781
First Posted
December 9, 2014
Last Updated
May 8, 2018
Sponsor
Pacific Parkinson's Research Centre
1. Study Identification
Unique Protocol Identification Number
NCT02315781
Brief Title
tDCS in Parkinson's Disease With Depression
Official Title
Parkinson's Disease Depression and tDCS
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Resources to conduct study withdrawn
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 6, 2017 (Actual)
Study Completion Date
December 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pacific Parkinson's Research Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Parkinson's
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS
Arm Type
Active Comparator
Arm Description
active tDCS will be used on half of the study participants
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Sham tDCS will be used on half of the study participants
Intervention Type
Device
Intervention Name(s)
active tDCS
Intervention Description
transcranial direct current stimulation (tDCS), is a type of electrical stimulation for the brain
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
Sham tDCS will appear exactly the same as active tDCS, but no stimulation will be administered.
Primary Outcome Measure Information:
Title
HAMD score
Description
an assessment of the severity of depression
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Dopamine levels
Description
PET scanning will be used to assess dopamine levels before and after sham/active tDCS in 20 participants
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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,
are taking a non-SSRI antidepressant medication,
are pregnant (women of childbearing age only).
Exclusion Criteria for PET:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A.J Stoessl, MD
Organizational Affiliation
Pacific Parkinson's Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pacific Parkinson's Research Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
12. IPD Sharing Statement
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tDCS in Parkinson's Disease With Depression
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