TMS in Aphasia Recovery

NCT04777214 | Completed Results DMC FDA Device

• 1 other identifier: 805362
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke often causes substantial problems in speaking or understanding speech. Treatments for these problems are currently very limited. Limited studies to date suggest that repetitive Transcranial Magnetic Stimulation (TMS) to the side of the brain opposite to the side on which the stroke occurred may improve language function. The investigators are testing this hypothesis by giving daily 20 minute sessions of repeated TMS to the right (unaffected) side of the brain; the investigators test language function with a variety of tests both before and after the treatment with TMS and subjects are required to undergo functional MRI scans before and after treatment. TMS is a procedure in which a coil is placed next to the head of the subject and an electrical current passes through the coil causing a magnetic field that, in turn, causes a small electric current in the portion of the brain underneath the coil.

Conditions

Aphasia

Outcome Measures

Primary Outcomes (1)

• Boston Naming Test

  The Boston Naming Test is an assessment of confrontation naming, where a score ranges from 0 (no items named correctly) to 36 (all items named correctly)

  Baseline, 2 months and 6-months after the last rTMS treatment session

Other Outcomes (3)

• Picture Description of the Boston Diagnostic Aphasia Exam

  Baseline and 2 months after the last rTMS treatment session

• Boston Diagnostic Aphasia Exam - Word Discrimination Subtest

  Baseline and 2 months after the last rTMS treatment session

• Boston Diagnostic Aphasia Examination - Commands Subtest

  Baseline and 2 months after the last rTMS treatment

Study Arms (2)

Active TMS

ACTIVE COMPARATOR

There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.

Device: Repetitive Transcranial Magnetic Stimulation

Sham TMS

SHAM COMPARATOR

There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz TMS are delivered, however, the coil will be rotated 90 degrees during stimulation.

Device: Sham TMS

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

Active TMS will be at 90% motor threshold

Active TMS

Sham TMS DEVICE

Sham TMS will be administered

Sham TMS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aphasic patients will have had single, unilateral left hemisphere ischemic stroke, which spared the supplementary motor area (SMA)
• With the exception of lacunar infarcts less than ≤ 1.5 cm (as measured by neuroimaging), the stroke causing the patients' impairments must be the only stroke.
• Aphasic patients will be at least 6 months post-stroke and have mild-severe, non-fluent speech
• Participants must be able to understand the nature of the study, and give informed consent

You may not qualify if:

• Patients with more than one stroke
• Intracranial metallic bodies from prior neurosurgical procedure
• Signs of increased intracranial pressure as assessed by ophthalmic exam and patient symptoms
• Implanted pacemaker, medication pump, vagal nerve stimulator, deep brain stimulator, TENS unit or ventriculoperitoneal shunt
• History of seizure or unexplained loss of consciousness during the year prior to the initiation of the study
• Family history of epilepsy
• Acute, unstable medical conditions
• History of substance abuse within the last 6 months
• Abnormal neurologic exam other than as signs of the condition studied in the present protocol
• History of known structural brain abnormality other than as signs of the condition studied in the present protocol
• History of tinnitus
• History of bipolar disorder
• Consumption of medicines known to lower the seizure threshold
• History of head injury with unconsciousness lasting more than 5 minutes
• Previous brain surgery

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Aphasia

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Samuel Cason
• Organization: University of Pennsylvania

sacason@pennmedicine.upenn.edu

215-573-4336

Study Officials

• H. Branch Coslett, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The procedure for localizing the site of stimulation and TMS administration will be identical to the treatment arm, except the coil will be rotated 90 degrees during the process/administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Model Details: The study involves two arms. The study involves a sham treatment control for half of the patients; all patients randomized to the sham treatment will be enrolled in the treatment phase after completing the sham treatment. Patients will be randomly assigned to the treatment arm or the sham treatment arm of the study. There are 3 phases: a pre-treatment evaluation phase in which baseline language and imaging data are obtained and the optimal site for stimulation is determined; a treatment phase during which TMS is delivered on 10 occasions; and a post-treatment phase during which effects of the treatment will be assessed using behavioral measures as well as fMRI at 2 and 6-months. Participants in the sham arm will undergo the same behavioral testing, MRI, and fMRI that will be administered in the treatment protocol. After the 2-month follow up visit, patients in the sham arm will be told that they did not receive real TMS and will be offered the opportunity to enter the treatment arm.

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: March 2, 2021
• Study Start: June 26, 2007
• Primary Completion: August 30, 2011
• Study Completion: August 30, 2011
• Last Updated: November 26, 2021
• Results First Posted: November 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)