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

September 29, 2017 updated by: Andrew Goldfine, Stony Brook University
The purpose of this study is to test the efficacy and safety of tDCS (Transcranial Direct Current Stimulation) on apathy in stroke patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Neuroelectrics Starstim

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in Apathy Inventory Scale - Subject
Time Frame: before and after each stimulation within 2 hours.
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.
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)
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.
before and after each stimulation within 2 hours.
Changes in Cognitive Tasks
Time Frame: before and after each stimulation within 2 hours.
before and after each stimulation within 2 hours.
Changes in EEG
Time Frame: before and after each stimulation within 2 hours.
before and after each stimulation within 2 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Collaborators

National Center of Neuromodulation for Rehabilitation

Investigators

  • Principal Investigator: Andrew M Goldfine, MD, Stony Brook Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

September 20, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Actual)

October 3, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 798869

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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