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

NCT02915484 | Terminated

• 1 other identifier: 798869
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Apathy; Stroke

Keywords

Transcranial Direct Current Stimulation; Apathy; Stroke; Empathy; Electric Stimulation Therapy; Depression; Anhedonia; Prefrontal Cortex; Electroencephalography; Cognition; Emotions; Neurological Rehabilitation; Brain Diseases; Cerebrovascular Disorders

Outcome Measures

Primary Outcomes (1)

• Changes in Apathy Inventory Scale - Clinician

  at the beginning of each session and 1 day after each session.

Secondary Outcomes (6)

• Changes in Apathy Inventory Scale - Subject

  before and after each stimulation within 2 hours.

• Changes in Apathy Inventory Scale - Family/Caregiver

  at the beginning of each session and 1 day after each session.

• Actimeter

  Actimeter is worn from the beginning of the study to end of study (20 to 30 days)

• Changes in Language Analysis tests

  before and after each stimulation within 2 hours.

• Changes in Cognitive Tasks

  before and after each stimulation within 2 hours.

Study Arms (2)

tDCS stimulation A

EXPERIMENTAL

Intervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex.

Device: Transcranial Direct Current Stimulation

tDCS stimulation B

EXPERIMENTAL

Intervention: Transcranial Direct Current Stimulation (tDCS) Up to 20 minutes of tDCS applied to the prefrontal cortex.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

TDCS involves sending a weak electrical current to the brain to modulate brain functions.

Also known as: Neuroelectrics Starstim

tDCS stimulation A; tDCS stimulation B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead
• National Center of Neuromodulation for Rehabilitation: collaborator

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Related 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):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.

  PMID: 22037126 BACKGROUND

• 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. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.

  PMID: 17452283 BACKGROUND

MeSH Terms

Conditions

Lethargy; Stroke; Depression; Anhedonia; Brain Diseases; Cerebrovascular Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Andrew M Goldfine, MD

  Stony Brook Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 27, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)