Transcranial Direct Current Stimulation (tDCS) in Chronic Post-Stroke Apathy "TDCS-PSA"

Terminated

Phase N/A Results N/A

Trial Description

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.

Trial Stopped: Difficulty with recruitment.

Conditions

Interventions

  • Transcranial direct current stimulation Device
    Other Names: tDCS
    Intervention Desc: TDCS involves sending a weak electrical current to the brain to modulate brain functions.
    ARM 1: Kind: Experimental
    Label: tDCS stimulation A
    Description: Intervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex.
    ARM 2: Kind: Experimental
    Label: tDCS stimulation B
    Description: Intervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Changes in Apathy Inventory Scale - Clinician at the beginning of each session and 1 day after each session. No
Secondary Changes in Apathy Inventory Scale - Subject before and after each stimulation within 2 hours. No
Secondary Changes in Apathy Inventory Scale - Family/Caregiver at the beginning of each session and 1 day after each session. No
Secondary Actimeter Actimeter is worn from the beginning of the study to end of study (20 to 30 days) No
Secondary Changes in Language Analysis tests before and after each stimulation within 2 hours. No
Secondary Changes in Cognitive Tasks before and after each stimulation within 2 hours. No
Secondary Changes in EEG before and after each stimulation within 2 hours. No

Sponsors