Evaluating Anodal tDCS Preceding Aphasia Therapy

NCT02249819 | Terminated Phase 1 Results

• 1 other identifier: 14-416
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if non-invasive brain stimulation (transcranial direct current stimulation) delivered prior to language therapy will improve word-finding in individuals with aphasia who are 6 months or greater post-stroke.

Conditions

Stroke; Aphasia

Keywords

stroke; aphasia; CVA; apraxia; cerebrovascular accident; cerebral stroke; speech therapy; aphasia therapy; non-invasive brain stimulation; transcranial direct current stimulation; tDCS

Outcome Measures

Primary Outcomes (1)

• Mean Change in Picture-naming Accuracy Score

  The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).

  baseline, discharge

Study Arms (2)

anodal tDCS, then sham tDCS

EXPERIMENTAL

Participants received 1 single 20 min session of anodal tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of sham tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants.

Device: transcranial direct current stimulation

sham tDCS, then anodal tDCS

EXPERIMENTAL

Participants received 1 single 20 min session of sham tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of anodal tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants.

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

Soterix 1x1 anodal tDCS

anodal tDCS, then sham tDCS; sham tDCS, then anodal tDCS

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years of age
• First single focal unilateral left hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
• Pre-morbidly right handed
• Pre-morbidly fluent English speaker
• Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist)
• A baseline Aphasia Quotient score between 10 to 94 out of 100 points on the Western Aphasia Battery (neither completely without language comprehension/expression nor fully recovered from aphasia).

You may not qualify if:

• Ongoing use of CNS-active medications
• Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
• Presence of additional potential tDCS risk factors:
• Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
• Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system
• Metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation)
• A history of medication-resistant epilepsy in the family
• Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months
• Pregnancy in women, as determined by self-report

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Related Publications (5)

• Monti A, Cogiamanian F, Marceglia S, Ferrucci R, Mameli F, Mrakic-Sposta S, Vergari M, Zago S, Priori A. Improved naming after transcranial direct current stimulation in aphasia. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):451-3. doi: 10.1136/jnnp.2007.135277. Epub 2007 Dec 20.

  PMID: 18096677 BACKGROUND

• Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.

  PMID: 20395612 BACKGROUND

• Fiori V, Coccia M, Marinelli CV, Vecchi V, Bonifazi S, Ceravolo MG, Provinciali L, Tomaiuolo F, Marangolo P. Transcranial direct current stimulation improves word retrieval in healthy and nonfluent aphasic subjects. J Cogn Neurosci. 2011 Sep;23(9):2309-23. doi: 10.1162/jocn.2010.21579. Epub 2010 Oct 14.

  PMID: 20946060 BACKGROUND

• Holland R, Crinion J. Can tDCS enhance treatment of aphasia after stroke? Aphasiology. 2012 Sep;26(9):1169-1191. doi: 10.1080/02687038.2011.616925. Epub 2011 Nov 3.

  PMID: 23060684 BACKGROUND

• Marangolo P, Fiori V, Campana S, Calpagnano MA, Razzano C, Caltagirone C, Marini A. Something to talk about: enhancement of linguistic cohesion through tdCS in chronic non fluent aphasia. Neuropsychologia. 2014 Jan;53:246-56. doi: 10.1016/j.neuropsychologia.2013.12.003. Epub 2013 Dec 11.

  PMID: 24333381 BACKGROUND

MeSH Terms

Conditions

Stroke; Aphasia; Apraxias; Communication Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Psychomotor Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Johanna Chang, Senior Research Coordinator
• Organization: Northwell Health

jchang14@northwell.edu

(516)562-3646

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sequence of stimulation conditions was randomized across subjects.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants received both stimulation conditions (active tDCS + computerized naming therapy and sham tDCS + computerized naming therapy), separated by a 1-week washout period.

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 26, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 5, 2021
• Results First Posted: April 6, 2018

Record last verified: 2019-02

Locations

US (1)