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Trial record 1 of 2 for:    post-stroke apathy
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Transcranial Direct Current Stimulation (tDCS) in Chronic Post-Stroke Apathy (TDCS-PSA)

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Andrew Goldfine, Stony Brook University
Sponsor:
Collaborator:
National Center for Neuromodulation for Rehabilitation
Information provided by (Responsible Party):
Andrew Goldfine, Stony Brook University
ClinicalTrials.gov Identifier:
NCT02915484
First received: September 20, 2016
Last updated: September 23, 2016
Last verified: September 2016
  Purpose
The purpose of this study is to test the efficacy and safety of tDCS (Transcranial Direct Current Stimulation) on apathy in stroke patients.

Condition Intervention
Apathy Stroke Device: Transcranial Direct Current Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) in Chronic Post-Stroke Apathy

Further study details as provided by Andrew Goldfine, Stony Brook University:

Primary Outcome Measures:
  • Changes in Apathy Inventory Scale - Clinician [ Time Frame: at the beginning of each session and 1 day after each session. ]

Secondary Outcome Measures:
  • Changes in Apathy Inventory Scale - Subject [ Time Frame: before and after each stimulation within 2 hours. ]
  • Changes in Apathy Inventory Scale - Family/Caregiver [ Time Frame: at the beginning of each session and 1 day after each session. ]
  • Actimeter [ Time Frame: Actimeter is worn from the beginning of the study to end of study (20 to 30 days) ]
  • Changes in Language Analysis tests [ Time Frame: before and after each stimulation within 2 hours. ]
  • Changes in Cognitive Tasks [ Time Frame: before and after each stimulation within 2 hours. ]
  • Changes in EEG [ Time Frame: before and after each stimulation within 2 hours. ]

Estimated Enrollment: 12
Study Start Date: June 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tDCS stimulation A
Intervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex.
Device: Transcranial Direct Current Stimulation
TDCS involves sending a weak electrical current to the brain to modulate brain functions.
Other Name: Neuroelectrics Starstim
Experimental: tDCS stimulation B
Intervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex.
Device: Transcranial Direct Current Stimulation
TDCS involves sending a weak electrical current to the brain to modulate brain functions.
Other Name: Neuroelectrics Starstim

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02915484

Contacts
Contact: Andrew M Goldfine, MD 914-269-8454 Andrew.Goldfine@stonybrookmedicine.edu
Contact: Ryan Patterson, BS 631-638-1562 ryan.patterson@stonybrookmedicine.edu

Locations
United States, New York
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794
Contact: Andrew M Goldfine, MD    914-269-8454    andrew.goldfine@stonybrookmedicine.edu   
Contact: Ryan Patterson, BS    631-638-1562    ryan.patterson@stonybrookmedicine.edu   
Sponsors and Collaborators
Stony Brook University
National Center for Neuromodulation for Rehabilitation
Investigators
Principal Investigator: Andrew M Goldfine, MD Stony Brook Medicine
  More Information

Publications:
Responsible Party: Andrew Goldfine, MD, Stony Brook University
ClinicalTrials.gov Identifier: NCT02915484     History of Changes
Other Study ID Numbers: 798869
Study First Received: September 20, 2016
Last Updated: September 23, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Andrew Goldfine, Stony Brook University:
Apathy
Transcranial Direct Current Stimulation
Stroke
Empathy
Electric Stimulation Therapy
Depression
Anhedonia
Prefrontal Cortex
Electroencephalography
Cognition
Emotions
Neurological Rehabilitation
Brain Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2017