Clinical Trial: Transcranial Direct Current Stimulation (tDCS) in Chronic Post-Stroke Apathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Transcranial Direct Current Stimulation (tDCS) in Chronic Post-Stroke Apathy

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 Summary:

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 giv
Sponsor: Stony Brook University

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. ]


Original Secondary Outcome: Same as current

Information By: Stony Brook University

Dates:
Date Received: September 20, 2016
Date Started: June 2016
Date Completion: January 2018
Last Updated: September 23, 2016
Last Verified: September 2016