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Trial record 66 of 173 for:    Recruiting, Not yet recruiting, Available Studies | psychiatric disorder OR bipolar OR depression | Brain Stimulation

Non-invasive Brain Stimulation Using Transcranial Direct Current Stimulation for Neuropsychiatric Symptoms of Dementia

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ClinicalTrials.gov Identifier: NCT03638284
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Sanjeev Kumar, Centre for Addiction and Mental Health

Brief Summary:
Agitation and aggression impose a tremendous burden on the individuals living with dementia, their families, caregivers, and healthcare systems. Neuropsychiatric symptoms of dementia (NPS) affect up to 80% of patients with Alzheimer's dementia. These symptoms impair patient and care giver's quality of life, increase the chances of hospitalization and also result in faster progression of the illness. The efficacy of current treatments is limited and the antipsychotic medications commonly used to treat these symptoms are associated with serious side effects. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that uses a very low intensity electric current to modulate cortical excitability and brain plasticity. tDCS can be safely administered to awake persons and is very well tolerated. In this study the investigators will use tDCS to treat agitation related to NPSD.

Condition or disease Intervention/treatment Phase
Dementia; Alzheimer, Mixed Type (Etiology) Device: Transcranial Direct Current Stimulation Not Applicable

Detailed Description:
Agitation and aggression impose a tremendous burden on the individuals living with dementia, their families, caregivers, and healthcare systems. Neuropsychiatric symptoms of dementia (NPS) affect up to 80% of patients with Alzheimer's dementia. These symptoms include aggression and agitation, anxiety, depression, hallucinations, and delusions. These symptoms impair patient and care giver's quality of life, increase the chances of hospitalization and also result in faster progression of the illness. The efficacy of current treatments is limited and the antipsychotic medications commonly used to treat these symptoms are associated with serious side effects including cerebrovascular events, falls and increased risk of death. Electroconvulsive Therapy may be effective as well, however it requires anaesthesia and adversely affects cognition. Non-pharmacological or behavioral interventions are universally recognized as the first line treatment for agitation and NPSD. They are most effective when individualized and delivered in a person centered approach. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that uses a very low intensity electric current to modulate cortical excitability and brain plasticity. tDCS can be safely administered to awake persons and is very well tolerated. Studies in healthy individuals and patients with Alzheimer's disease have shown that tDCS applied to frontal brain regions can enhance cognitive function. Further, tDCS applied to frontal brain regions can improve depressive symptoms. The effects of tDCS on NPSD are not known. In this study the investigators will use tDCS to treat agitation related to NPSD.The objective of this proposal is to conduct an open label pilot study of tDCS for treatment of agitation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All enrolled study participants will receive 10 sessions (5 per week X 2 weeks) of tDCS in an open label study. Participants will have neurocognitive assessments at baseline and at study completion (i.e. the last day of receiving tDCS).
Masking: None (Open Label)
Masking Description: N/a-open label study
Primary Purpose: Treatment
Official Title: Non Invasive Brain Stimulation for Treatment of Neuropsychiatric Symptoms of Dementia: An Open Label Pilot Study Using Transcranial Direct Current Stimulation
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation (tDCS):All enrolled study participants will receive 10 sessions (5 per week X 2 weeks) of tDCS in an open label study. Inhibitory stimulation will be delivered to the frontal lobes.
Device: Transcranial Direct Current Stimulation
tDCS is a non-invasive brain stimulation that does not require general anaesthesia or surgical implantation of a device. It uses two AA size batteries to deliver direct current via rubber electrodes enclosed in saline soaked sponges.




Primary Outcome Measures :
  1. The rate of successful completion of the 2 week tDCS treatment course and rates of treatment associated adverse effects of tDCS in agitation due to NPSD [ Time Frame: 2 weeks ]
    This will be assessed by the successful completion of the intervention in at least 80% of participants without any treatment associated serious adverse effects


Secondary Outcome Measures :
  1. Effects of a 2 week course of tDCS on agitation as assessed by Cohen Mansfield Agitation Inventory (CMAI). [ Time Frame: 2 weeks, 4 weeks ]
    Patients who undergo tDCS course will have reduced neuropsychiatric symptoms assessed using the Cohen Mansfield Agitation Inventory (CMAI). tDCS will result in a significant reduction in agitation as assessed by CMAI -frequency total score between baseline and post treatment follow up two weeks later. CMAI-frequency score ranges between 29 to 203 and CMAI-disruptiveness ranges from 29 to 145 for each category. Higher scores indicate worsening of symptoms.

  2. Effects of a 2 week course of tDCS on agitation as assessed by Neuropsychiatric Inventory (NPI). [ Time Frame: 2 weeks, 4 weeks ]
    Patients who undergo tDCS course will have reduced neuropsychiatric symptoms assessed using the Neuropsychiatric Inventory (NPI). tDCS will result in reduced burden of neuropsychiatric symptoms as assessed by Neuropsychiatric Inventory after the 2 week intervention. Each NPI domain is scored based on the interview conducted by the clinician. Frequency of symptoms are rated on a scale of 0 - 4 (Higher scores indicate symptoms occur more frequently). Severity / intensity of symptoms are rated on a scale of 0 to 3 (Higher scores indicate greater severity of symptoms). Caregiver distress is rated on a scale of 0 to 5 (Higher scores indicate increased caregiver distress).

  3. Effects of a 2 week course of tDCS on agitation and other neuropsychiatric symptoms related to dementia as assessed by Clinical Global Impression (CGI). [ Time Frame: 2 weeks, 4 weeks ]
    Patients who undergo tDCS course will have reduced neuropsychiatric symptoms as assessed using Clinical Global Impression -Improvement Scale CGI-I. tDCS will result in a significant improvement in clinical symptoms as assessed by CGI-I scale after the two week intervention. CGI-I scores range from 0-7, higher scores indicating worsening compared to at baseline.

  4. Effect of tDCS on caregiver burden in agitation due to NPSD as assessed by Zarit Burden Interview (ZBI) [ Time Frame: 2 weeks ]
    tDCS will result in significant reduction in caregiver burden as assessed by Zarit Burden Interview (ZBI). Scores on the ZBI range from 0 to 88, score of 0-21 indicating little or no burden; 21-40 indicating mild to moderate burden; 41-60 indicating moderate to severe burden; and 61-88 indicating severe burden.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A clinical diagnosis of Dementia of Alzheimer's, or Mixed type.
  2. Presence of agitation and/or aggression related to NPS as defined by: Agitation in cognitive disorders; International Psychogeriatric Association Provisional Consensus Clinical and Research Definition at the time of enrolment into the study.
  3. Patient or Substitute Decision Maker (SDM) able and willing to provide consent for enrolment in the study.
  4. Age 60 or above

Exclusion Criteria:

  1. Having dementia other than Alzheimer's or Vascular or Mixed type.
  2. DSM-5 Axis I diagnoses other than dementia that is thought to be significantly impacting the presentation such as bipolar disorder, major depressive disorder, or schizophrenia
  3. Imminent safety risk that would interfere with safe conduct of the study.
  4. Any contraindication to tDCS such as metal implants in cranium.

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): NCT03638284


Contacts
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Contact: Shima Ovaysikia, MA 416 535-8501 ext 32589 shima.ovaysikia@camh.ca
Contact: Dunja Knezevic, MSc 416 535-8501 ext 32796 dunja.knezevic@camh.ca

Locations
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Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M6J 1H4
Contact: Sanjeev Kumar, MD, FRCPC    426-535-8501 ext 39384    sanjeev.kumar@camh.ca   
Contact: Shima Ovaysikia, MA    416-535-8501 ext 32589    shima.ovaysikia@camh.ca   
Sub-Investigator: Daniel Blumberger, MD,MS,FRCPC         
Sub-Investigator: Peter Derkach, MD, CFPC         
Sub-Investigator: Tarek Rajji, MD, FRCPC         
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Sanjeev Kumar, MD, FRCPC CAMH

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Responsible Party: Sanjeev Kumar, Medical Head of Geriatric Clinical Research, Centre for Addiction and Mental Health; Clinician Scientist and Staff Psychiatrist, Campbell Family Mental Health Research Institute; Assistant Professor of Psychiatry, University of Toronto., Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03638284     History of Changes
Other Study ID Numbers: 099/2017
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanjeev Kumar, Centre for Addiction and Mental Health:
Dementia
neuropsychiatric symptoms
tDCS
Transcranial direct current stimulation
Alzheimer Disease
Mixed Dementia
agitation in dementia
non-invasive brain stimulation
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders