Transcranial Direct Current Stimulation (tDCS) in Post-Stroke Working Memory Deficits

Stroke Clinical Trial

— TDCS-PSMWD  

Official title:

Transcranial Direct Current Stimulation (tDCS) in Post-Stroke Working Memory Deficits

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03034109
• Other study ID #: 986244
• Status: Terminated
• Phase: N/A
• First received: January 24, 2017
• Last updated: October 19, 2017
• Start date: January 2017
• Est. completion date: June 2017

Study information

• Verified date: October 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 effects of tDCS (Transcranial Direct Current Stimulation) on stroke patients with working memory problems.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• 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).

• 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.

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Deficit
• Cognitive Dysfunction
• Cognitive Impairment
• Memory Disorders
• Short-Term Memory Impairment
• 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 (3)

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):641-61. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15. Review. — View 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):175-95. 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 Cognitive Test Battery	A series of cognitive tests will be conducted before and after each stimulation. The tests will include a n-back test (0,1,2), a delayed recognition task, and a number capacity task.	before and after each stimulation within 2 hours.
Secondary	Changes in Auditory Digit Span Test	An auditory digit span test (forward and backward) will be asked over phone 4 times.	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