Cerebellar Transcranial Direct Current Stimulation and Aphasia Treatment

NCT02901574 | Completed Results

• 2 other identifiers: IRB00100024R00DC015554
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

People with post-stroke aphasia are left with some degree of chronic deficit for which current rehabilitative treatments are variably effective. This study investigates the behavioral and neural effects of multiple consecutive cerebellar tDCS sessions coupled with computerized naming therapy in stroke survivors with aphasia.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test:PNT) Pre-treatment to Post-treatment

  To determine whether tDCS coupled with computerized naming therapy will improve naming performance of participants with post stroke aphasia more effectively than naming therapy alone (i.e., the sham condition).The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance.

  Before and after 15 sessions (3-5 sessions per week; up to 5 weeks) of treatment.

Secondary Outcomes (11)

• Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test:PNT)Pre-treatment to 2 Weeks Post-treatment.

  Pre-treatment and at 2 weeks Post-treatment

• Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test:PNT) Pre-treatment to 2 Months Post-treatment.

  Pre-treatment and at 2 months Post-treatment

• Change in Functional Communication Skills on the ASHA-FACS Communication Independence Scale Pre-treatment to Post-treatment

  Before and after 15 sessions (3-5 sessions per week; up to 5 weeks) of treatment.

• Change in Functional Communication Skills on the ASHA-FACS Communication Independence Scale Pre-treatment to 2 Weeks Post-treatment

  Pre-treatment and at 2 weeks Post-treatment

• Change in Functional Communication Skills on the ASHA-FACS Communication Independence Scale Pre-treatment to 2 Months Post-treatment

  Pre-treatment and at 2 months Post-treatment

Study Arms (2)

tDCS plus computerized naming therapy

ACTIVE COMPARATOR

Anodal or cathodal tDCS, 2 milliamps (mA) plus computerized naming treatment for 15 sessions (20 minutes per each 45 minute treatment session) over the course of 3-5 weeks.The electrical current will be administered to the right cerebellum. The stimulation will be delivered at an intensity of 2 mA for a maximum of 20 minutes. Language therapy will be a computer delivered naming +picture matching task.

Device: Anodal or Cathodal tDCS; Behavioral: Computerized naming therapy

Sham plus computerized naming therapy

SHAM COMPARATOR

Sham tDCS plus computerized naming treatment for 15 sessions (20 minutes per each 45 minute treatment session) over the course of 3-5 weeks. Current will be administered in the in a ramp like fashion for 15-30 seconds but then the current is gradually decreased and drop to 0 mA. Language therapy will be a computer delivered naming +picture matching task.

Device: Sham; Behavioral: Computerized naming therapy

Interventions

Anodal or Cathodal tDCS DEVICE

2 mA or Anodal or Cathodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge (anode in group anode or cathode in group cathode) is placed on the right cerebellum. The stimulation will be delivered at an intensity of 2 mA in a ramp-like fashion for a maximum of 20 minutes.

tDCS plus computerized naming therapy

Sham DEVICE

2 mA of Anodal tDCS or Cathodal tDCS is induced between two 5cm X 5cn saline soaked sponges where one sponge (anode in group Anode and cathode in group Cathode) is placed on the right cerebellum. Ramping up of the current to 2 mA occurs over 15-30 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.

Sham plus computerized naming therapy

Computerized naming therapy BEHAVIORAL

Computer delivered naming treatment requires matching (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red button if the word does not match the picture.

Sham plus computerized naming therapy; tDCS plus computerized naming therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have sustained a left hemisphere stroke.
• Participants must be fluent speakers of English by self-report.
• Participants must be capable of giving informed consent or indicating another to provide informed consent.
• Participants must be age 18 or older.
• Participants must be premorbidly right handed.
• Participants must be at least 6 months post stroke.
• Participants must have an aphasia diagnosis as confirmed by the Boston Diagnostic Aphasia Examination (BDAE) Short Form.
• Participants must achieve at least 65% accuracy on screening task (comparable to treatment task) on 1 of 3 attempts

You may not qualify if:

• Participants with lesion involving the right cerebellum
• Previous neurological or psychiatric disease.
• Seizures during the previous 12 months.
• Uncorrected visual loss or hearing loss by self-report.
• Use of medications that lower the seizure threshold (e.g., methylphenidate, amphetamine salts).
• Use of N-methyl-D-aspartate receptor (NMDA) antagonists (e.g., memantine).
• \> 80% (140 out of 175) correct responses on the Philadelphia Naming Test at baseline.
• History of brain surgery or any metal in the head.
• Scalp sensitivity (per participant report).

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Rajani Sebastian, PhD
• Organization: Johns Hopkins University School of Medicine

rsebast3@jhmi.edu

410-502-5012

Study Officials

• Rajani Sebastian, PhD, CCC-SLP

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 15, 2016
• Study Start: September 19, 2016
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: April 21, 2023
• Results First Posted: April 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)