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

Stroke Clinical Trial

— TDCS-PSA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02915484
• Other study ID #: 798869
• Status: Terminated
• Phase: N/A
• First received: September 20, 2016
• Last updated: September 29, 2017
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the efficacy and safety of tDCS (Transcranial Direct Current Stimulation) on apathy in stroke patients.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apathy
• Stroke

Intervention

Device:
• Transcranial Direct Current Stimulation
TDCS involves sending a weak electrical current to the brain to modulate brain functions.

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	National Center for Neuromodulation for Rehabilitation

Country where clinical trial is conducted

United States, 

References & Publications (2)

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):175-95. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1. Review. — View 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. Epub 2007 Jan 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Apathy Inventory Scale - Clinician		at the beginning of each session and 1 day after each session.
Secondary	Changes in Apathy Inventory Scale - Subject		before and after each stimulation within 2 hours.
Secondary	Changes in Apathy Inventory Scale - Family/Caregiver		at the beginning of each session and 1 day after each session.
Secondary	Actimeter		Actimeter is worn from the beginning of the study to end of study (20 to 30 days)
Secondary	Changes in Language Analysis tests		before and after each stimulation within 2 hours.
Secondary	Changes in Cognitive Tasks		before and after each stimulation within 2 hours.
Secondary	Changes in EEG		before and after each stimulation within 2 hours.