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

NCT ID: NCT02915484

Last Updated: 2017-10-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-06-30

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 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.

Conditions

Apathy; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

tDCS stimulation A

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

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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

tDCS stimulation B

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

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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

Interventions

Transcranial Direct Current Stimulation

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

Intervention Type: DEVICE

Other Intervention Names

Neuroelectrics Starstim

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center of Neuromodulation for Rehabilitation

OTHER

Sponsor Role: collaborator

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Andrew Goldfine

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew M Goldfine, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook Medicine

Locations

Stony Brook University

Stony Brook, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22037126 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17452283 (View on PubMed)

Other Identifiers

798869

Identifier Type: -

Identifier Source: org_study_id