TMS as a Biological Marker of Neuroplasticity

NCT02867670 | Completed

• 1 other identifier: 818784
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

TMS is a non-invasive brain stimulation technique, which can be used to change the activity of a person's brain cells without needles or surgery. In this study, the invesigators are interested in the brain's ability to adapt (also called "neuroplasticity") and regain language functioning after a stroke-specifically, they want to determine whether how a person's brain responds to TMS in the short term can be used to predict how well they will recover language abilities in the long term.

Conditions

Stroke; Aphasia

Keywords

Transcranial Magnetic Stimulation (TMS)

Outcome Measures

Primary Outcomes (2)

• Transient TBS-induced changes in motor evoked potentials (MEPs)

  Single-Pulse TMS will be used to measure MEPs prior to and after stimulation. When measuring MEPs, single pulses of TMS will be administered at approximately 120% of motor threshold, and with a minimum interstimulus interval of 5 seconds. Mean MEP amplitudes will be calculated by averaging the MEP amplitudes generated by 20 pulses. MEP measures will be obtained three times in order to establish a stable baseline. This procedure will be followed by TBS delivered to the optimal site in the motor cortex. TBS will be applied to the region of the primary motor cortex (M1) representing the hand. After TBS, MEPs will be acquired, at 0-, 10-, 20-, 30-, 40-, and 60-min post-stimulation.

  Up to 2 week

• Transient TBS-induced changes in language performance

  Participants will be asked to perform a 40-item picture naming task pre/post TBS stimulation. Stimulation will occur at language cortex and vertex (order will be counterbalanced). Transient changes in naming abilities will be measured directly by assessing naming performance.

  Up to 4 weeks

Secondary Outcomes (1)

• Safety and Tolerability of TBS in patient with aphasia

  Through study completion

Study Arms (2)

Transcranial Magnetic Stimulation of Motor Cortex

All study participants will receive real TMS stimulation over the primary motor cortex in order to collect physiological measures which will later be correlated with measures of neuroplasticity. There is NO placebo stimulation.

Device: Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation of Language Cortex

All study participants will receive real TMS stimulation over the language cortex and a control site (i.e. vertex). Transient changes in speech production will be recorded and compared to measures of neuroplasticity. There is NO placebo stimulation.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

TMS is a form of non-invasive brain stimulation which uses magnetic pulses to stimulate regions of the brain from outside the head, on the scalp. Specifically, TMS is performed with a copper-and-plastic coil that emits a magnetic field, which can affect brain cells in specific locations. In this study, researchers will also use a form of TMS called theta-burst stimulation (TBS), where TMS pulses are delivered rapidly over time.

Also known as: TMS

Transcranial Magnetic Stimulation of Language Cortex; Transcranial Magnetic Stimulation of Motor Cortex

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who have had one or more strokes and are now experiencing the symptoms of aphasia. Aphasia is a communication disorder which may result in difficulties speaking,understanding speech, or both.

You may qualify if:

• Must have Aphasia due to stroke
• Stroke must have occurred at least 6 months ago
• Native English speaker
• Willing \& able to have a MRI

You may not qualify if:

• Disorders of the brain other than stroke (i.e. tumor, Parkinsons, cancer... etc.)
• History of seizures/ or epilepsy
• Pacemaker or other implanted electronic devices
• Consumption of medications that lower seizure threshold
• History of psychiatric disorders
• History of tinnitus
• Current abuse of drugs or alcohol
• Pregnant or plan to get pregnant

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Lab Website

Biospecimen

Retention: SAMPLES WITH DNA

The investigators are asking participants to provide a saliva sample which will later be genotyped for the BDNF protein. Saliva samples are optional.

MeSH Terms

Conditions

Stroke; Aphasia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Roy H Hamilton, MD, MS

  Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: August 16, 2016
• Study Start: July 1, 2013
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

US (1)