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
|Condition or disease||Intervention/treatment||Phase|
|Dementia; Alzheimer, Mixed Type (Etiology)||Device: Transcranial Direct Current Stimulation||Not Applicable|
|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|
|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|
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.
- 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
- 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.
- 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).
- 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.
- 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.
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
|Contact: Shima Ovaysikia, MA||416 535-8501 ext firstname.lastname@example.org|
|Contact: Dunja Knezevic, MSc||416 535-8501 ext email@example.com|
|Centre for Addiction and Mental Health||Recruiting|
|Toronto, Ontario, Canada, M6J 1H4|
|Contact: Sanjeev Kumar, MD, FRCPC 426-535-8501 ext 39384 firstname.lastname@example.org|
|Contact: Shima Ovaysikia, MA 416-535-8501 ext 32589 email@example.com|
|Sub-Investigator: Daniel Blumberger, MD,MS,FRCPC|
|Sub-Investigator: Peter Derkach, MD, CFPC|
|Sub-Investigator: Tarek Rajji, MD, FRCPC|
|Principal Investigator:||Sanjeev Kumar, MD, FRCPC||CAMH|