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tDCS in Parkinson's Disease With Depression

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ClinicalTrials.gov Identifier: NCT02315781
Recruitment Status : Terminated (Resources to conduct study withdrawn)
First Posted : December 12, 2014
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
A. Jon Stoessl, Pacific Parkinson's Research Centre

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.

Condition or disease Intervention/treatment Phase
Depression Parkinson's Device: active tDCS Device: Sham tDCS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Parkinson's Disease Depression and tDCS
Study Start Date : January 2015
Actual Primary Completion Date : December 6, 2017
Actual Study Completion Date : December 6, 2017

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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.




Primary Outcome Measures :
  1. HAMD score [ Time Frame: 12 weeks ]
    an assessment of the severity of depression


Secondary Outcome Measures :
  1. Dopamine levels [ Time Frame: 12 weeks ]
    PET scanning will be used to assess dopamine levels before and after sham/active tDCS in 20 participants



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315781


Locations
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Canada, British Columbia
Pacific Parkinson's Research Centre
Vancouver, British Columbia, Canada, V6T 2B5
Sponsors and Collaborators
Pacific Parkinson's Research Centre
Investigators
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Principal Investigator: A.J Stoessl, MD Pacific Parkinson's Research Centre

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Responsible Party: A. Jon Stoessl, Co-Director of the Centre for Brain Health UBC, Pacific Parkinson's Research Centre
ClinicalTrials.gov Identifier: NCT02315781     History of Changes
Other Study ID Numbers: H14-00867
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Parkinson Disease
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases