Transcranial Direct Current Stimulation (tDCS) in Chronic Post-Stroke Apathy (TDCS-PSA)
Primary Purpose
Apathy, Stroke
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Apathy focused on measuring Transcranial Direct Current Stimulation, Apathy, Stroke, Empathy, Electric Stimulation Therapy, Depression, Anhedonia, Prefrontal Cortex, Electroencephalography, Cognition, Emotions, Neurological Rehabilitation, Brain Diseases, Cerebrovascular Disorders
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of stroke and radiographically proven ischemic or hemorrhagic stroke (MRI required for ischemic stroke, CT sufficient for hemorrhagic stroke)
- Stroke occurred at least one month prior to first stimulation session
- Ability to provide informed consent
- Availability of a family member / caregiver who knew the subject before the stroke and interacts with the subject on at least a weekly basis
- Score of 6 or higher in initial apathy testing using Apathy Inventory - Clinician score
- Speak English (required for quantifying apathy and performing the cognitive tests)
Exclusion Criteria:
- Other potential cause of apathy including some neurodegenerative diseases, some psychiatric diseases, and anti-dopamine medication
- Prior brain injury (e.g., Traumatic Brain Injury (TBI), stroke) without full motor and cognitive recovery based on patient, family or clinician report
- Active medical illness (e.g., infection, delirium, etc.) that might affect arousal and cognitive function
- Hypoarousal (inability to maintain eye opening without stimulation) from any cause (e.g., stroke, sleep deprivation)
- Any history of epilepsy
- Recent drug or alcohol abuse - within the past year
- Pregnant or breastfeeding
- Moderate to severe aphasia preventing subject from communicating fully
- Any pacemakers, intracranial electrodes, implanted defibrillators, or any other electrical implants
Sites / Locations
- Stony Brook University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
tDCS stimulation A
tDCS stimulation B
Arm Description
Intervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex.
Intervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex.
Outcomes
Primary Outcome Measures
Changes in Apathy Inventory Scale - Clinician
Secondary Outcome Measures
Changes in Apathy Inventory Scale - Subject
Changes in Apathy Inventory Scale - Family/Caregiver
Actimeter
Changes in Language Analysis tests
Changes in Cognitive Tasks
Changes in EEG
Full Information
NCT ID
NCT02915484
First Posted
September 20, 2016
Last Updated
September 29, 2017
Sponsor
Stony Brook University
Collaborators
National Center of Neuromodulation for Rehabilitation
1. Study Identification
Unique Protocol Identification Number
NCT02915484
Brief Title
Transcranial Direct Current Stimulation (tDCS) in Chronic Post-Stroke Apathy
Acronym
TDCS-PSA
Official Title
Transcranial Direct Current Stimulation (tDCS) in Chronic Post-Stroke Apathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
Difficulty with recruitment.
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
Collaborators
National Center of Neuromodulation for Rehabilitation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test the efficacy and safety of tDCS (Transcranial Direct Current Stimulation) on apathy in stroke patients.
Detailed Description
Post-stroke apathy is a condition where people show reduced emotions and reduced activity after their stroke, beyond that expected from their degree of weakness. It can occur with, or without, depression, and is associated with more disability and slower recovery. It is thought to be due to dysfunction of the front of the brain (prefrontal cortex). Importantly, there are no proven medical treatments for post-stroke apathy.
Transcranial direct current stimulation (tDCS) is a painless, noninvasive brain stimulation technique that has the potential for alleviating post-stroke apathy. TDCS involves sending a weak electrical current through the head, thereby exciting the brain underneath. This offers potential advantages over medications as tDCS directly targets the brain, while medications need to travel through the bloodstream to reach the brain. TDCS is not an FDA-approved treatment for any condition, but previous trials have shown it may benefit movement and language recovery after stroke, as well as improve thinking ability. Studies have shown tDCS to be very safe with no serious adverse events in over 10,000 subjects studied.
This pilot study will involve three visits to Stony Brook University Hospital. The first is a baseline session where subjects perform all outcome measures but no tDCS is performed other than for familiarization. The second and third sessions are the stimulation sessions where subjects undergo the intervention for 20 minutes to test tDCS effects on the outcome measures. The effects of tDCS for a single session are expected to only last for few hours. Subjects are to receive one type of stimulation in one session and another type in the other session. If this study finds a short term benefit of tDCS for post-stroke apathy it will support a full clinical trial where multiple sessions of tDCS will be given and may provide a long-term benefit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apathy, Stroke
Keywords
Transcranial Direct Current Stimulation, Apathy, Stroke, Empathy, Electric Stimulation Therapy, Depression, Anhedonia, Prefrontal Cortex, Electroencephalography, Cognition, Emotions, Neurological Rehabilitation, Brain Diseases, Cerebrovascular Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tDCS stimulation A
Arm Type
Experimental
Arm Description
Intervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex.
Arm Title
tDCS stimulation B
Arm Type
Experimental
Arm Description
Intervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
Neuroelectrics Starstim
Intervention Description
TDCS involves sending a weak electrical current to the brain to modulate brain functions.
Primary Outcome Measure Information:
Title
Changes in Apathy Inventory Scale - Clinician
Time Frame
at the beginning of each session and 1 day after each session.
Secondary Outcome Measure Information:
Title
Changes in Apathy Inventory Scale - Subject
Time Frame
before and after each stimulation within 2 hours.
Title
Changes in Apathy Inventory Scale - Family/Caregiver
Time Frame
at the beginning of each session and 1 day after each session.
Title
Actimeter
Time Frame
Actimeter is worn from the beginning of the study to end of study (20 to 30 days)
Title
Changes in Language Analysis tests
Time Frame
before and after each stimulation within 2 hours.
Title
Changes in Cognitive Tasks
Time Frame
before and after each stimulation within 2 hours.
Title
Changes in EEG
Time Frame
before and after each stimulation within 2 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of stroke and radiographically proven ischemic or hemorrhagic stroke (MRI required for ischemic stroke, CT sufficient for hemorrhagic stroke)
Stroke occurred at least one month prior to first stimulation session
Ability to provide informed consent
Availability of a family member / caregiver who knew the subject before the stroke and interacts with the subject on at least a weekly basis
Score of 6 or higher in initial apathy testing using Apathy Inventory - Clinician score
Speak English (required for quantifying apathy and performing the cognitive tests)
Exclusion Criteria:
Other potential cause of apathy including some neurodegenerative diseases, some psychiatric diseases, and anti-dopamine medication
Prior brain injury (e.g., Traumatic Brain Injury (TBI), stroke) without full motor and cognitive recovery based on patient, family or clinician report
Active medical illness (e.g., infection, delirium, etc.) that might affect arousal and cognitive function
Hypoarousal (inability to maintain eye opening without stimulation) from any cause (e.g., stroke, sleep deprivation)
Any history of epilepsy
Recent drug or alcohol abuse - within the past year
Pregnant or breastfeeding
Moderate to severe aphasia preventing subject from communicating fully
Any pacemakers, intracranial electrodes, implanted defibrillators, or any other electrical implants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew M Goldfine, MD
Organizational Affiliation
Stony Brook Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22037126
Citation
Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
Results Reference
background
PubMed Identifier
17452283
Citation
Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
Results Reference
background
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Transcranial Direct Current Stimulation (tDCS) in Chronic Post-Stroke Apathy
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