Clinical trial NCT03034109: Transcranial Direct Current Stimulation (tDCS) in Post-Stroke Working Memory Deficits
Official title: Transcranial Direct Current Stimulation (tDCS) in Post-Stroke Working Memory Deficits
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Cognitive Deficit
Cognitive Impairment
Short-Term Memory Impairment
Keywords: Transcranial Direct Current Stimulation
Stroke
Electric Stimulation Therapy
Prefrontal Cortex
Electroencephalography
Cognition
Neurological Rehabilitation
Memory
Working Memory
Attention
Concentration
Short-Term Memory
Planning
Executive Function
Cerebrovascular disease
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: National Center of Neuromodulation for Rehabilitation
First posted: 2017-01-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effects of tDCS (Transcranial Direct Current Stimulation) on stroke patients with working memory problems.

Detailed description: After having a stroke, people often have trouble remembering to do something, solving problems, or following conversations. They can also have trouble concentrating, following instructions, and multitasking. These can all due to the stroke affecting a brain function called "working memory". Working memory is defined as the ability to hold a thought in one's mind for a few seconds in order to remember a task or solve a problem. People have difficulty returning to their normal lives because of these working memory problems. Currently, there no proven medical treatments for working memory problems.

Transcranial direct current stimulation (tDCS) is a painless, noninvasive brain stimulation technique that has been shown in some studies to improve working memory in healthy subjects. TDCS involves sending a weak electrical current through the head, thereby exciting the brain underneath. 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 four 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 other three 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 will be receiving all three different types of stimulation. If this study finds a short term benefit of tDCS for post-stroke working memory deficits, it will support a full clinical trial where multiple sessions of tDCS will be given and may provide a long-term benefit.

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).
* Subject reports a decline in attention or short-term memory that began at the time of their stroke.
* Stroke occurred at least one month prior to first stimulation session.
* Ability to provide informed consent.
* Speak English (required for performing the cognitive tests)

Exclusion Criteria:

* Any other brain disease that can affect cognition (e.g., multiple sclerosis, dementia).
* Active mental illness such as depression or anxiety
* Large stroke involving cortex under the stimulation site (using subject provided CT or MRI).
* Currently taking any drugs that are sodium and/or calcium channel blockers not including amlodipine. This includes some seizure medications along with nicardipine, nifedipine, nimodipine, verapamil and diltiazem.
* Any history of epilepsy.
* Subject report of recent drug or alcohol abuse - within the past year.
* Subject report of pregnant or breastfeeding.
* Moderate to severe aphasia preventing subject from communicating fully.
* Any pacemakers, intracranial electrodes, implanted defibrillators, or any other electrical implants.

Primary outcomes:
measure: Changes in Cognitive Test Battery
timeFrame: before and after each stimulation within 2 hours.
Secondary outcomes:
measure: Changes in Auditory Digit Span Test
timeFrame: at baseline, once immediately after stimulation, one time in the evening of the session day and then one more time the day after the session
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook Medicine
name: Andrew M Goldfine, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
citation: 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.
citation: Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.