Post-Stroke Aphasia and Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment Study

NCT01512264 | Completed Results DMC

• 1 other identifier: R01HD068488
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators will examine the efficacy of navigated excitatory repetitive transcranial magnetic stimulation (nerTMS) for the treatment of post stroke aphasia. The investigators expect that this new types of rehabilitation (nerTMS) will help patients with aphasia return to their lives as they were prior to the stroke.

Conditions

Aphasia; Stroke

Keywords

Aphasia; Stroke; functional Magnetic resonance imaging; fMRI; Language recovery after stroke; constraint induced aphasia therapy; CIAT; Repetitive transcranial magnetic stimulation; rTMS

Outcome Measures

Primary Outcomes (12)

• Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline

  60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.

  Baseline: 1 week before the first nerTMS treatment

• Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Immediate Follow-Up

  60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.

  within 1 week post treatment

• Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Long Term Follow-up

  60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.

  3 months post treatment

• Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Baseline

  The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. "Animals", "Fruits") and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.

  1 week before the first nerTMS treatment

• Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Immediate Follow-up

  The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. "Animals", "Fruits") and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.

  within 1 week post treatment

• Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Long Term Follow-up

  The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. "Animals", "Fruits") and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.

  3 months post treatment

• Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Baseline

  The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. "C", "F", "L") and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.

  1 week before the first nerTMS treatment

• Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Immediate Follow-up

  The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. "C", "F", "L") and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.

  within 1 week post treatment

• Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Long Term Follow-up

  The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. "C", "F", "L") and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.

  3 months post treatment

• Western Aphasia Battery (WAB) - Baseline

  WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.

  Baseline: 1 week before the first nerTMS treatment

• Western Aphasia Battery (WAB) - Immediate Follow-Up

  WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.

  within 1 week post treatment

• Western Aphasia Battery (WAB) - Long-Term Follow-Up

  WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.

  3 months post treatment

Secondary Outcomes (9)

• Change in Language Laterilazation as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Baseline

  Baseline: 1 week before the first nerTMS treatment

• Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up

  within 1 week post treatment

• Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up

  3 months post treatment

• Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Baseline

  Baseline: 1 week before the first nerTMS treatment

• Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Immediate Follow Up

  within 1 week post treatment

Study Arms (4)

rTMS

EXPERIMENTAL

3 weeks of nerTMS

Device: Magstim SuperRapid

1 week of Sham Treatment + 2 weeks of nerTMS

SHAM COMPARATOR

1 week of Sham Treatment + 2 weeks of nerTMS

Device: Magstim SuperRapid

2 weeks of Sham Treatment +1 week of nerTMS

SHAM COMPARATOR

2 weeks of Sham Treatment +1 week of nerTMS

Device: Magstim SuperRapid

Control Group

PLACEBO COMPARATOR

3 weeks of Sham Treatment

Device: Magstim SuperRapid

Interventions

Magstim SuperRapid DEVICE

This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.

Also known as: Repetitive Transcranial Magnetic Stimulation, rTMS

1 week of Sham Treatment + 2 weeks of nerTMS; 2 weeks of Sham Treatment +1 week of nerTMS; Control Group; rTMS

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• LMCA stroke as indicated by the presence of aphasia and MRI lesion in the LMCA distribution
• Moderate aphasia (Token Test score between 40th and 90th percentile)
• Fluency in English
• Provision of written informed consent by the patient and/or the next of kin

You may not qualify if:

• Age less than 18 years
• Underlying degenerative or metabolic disorder or supervening medical illness
• Severe depression or other psychiatric disorder
• Positive pregnancy test in women of childbearing age
• Any contraindication to MRI/fMRI at 3T (i.e., intracranial metal implants, claustrophobia)
• Any contraindication to nerTMS (e.g., seizures or epilepsy)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Aphasia; Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Jerzy P. Szaflarski
• Organization: Universtiy of Alabama at Birmingham

jszaflarski@uabmc.edu

205.975.5587

Study Officials

• Jerzy P Szaflarski, MD, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 19, 2012
• Study Start: January 1, 2012
• Primary Completion: July 20, 2018
• Study Completion: July 20, 2018
• Last Updated: July 14, 2020
• Results First Posted: August 16, 2019

Record last verified: 2020-07

Locations

US (1)