Clinical trial NCT02867670: TMS as a Biological Marker of Neuroplasticity
Official title: TMS as a Biological Marker of Neuroplasticity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Aphasia
Keywords: Transcranial Magnetic Stimulation (TMS)
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: Aphasia is an impairment of language that may occur after a stroke (or other brain injuries). A person with aphasia may experience difficulties speaking, understanding speech, reading, writing, or any combination of these symptoms. Despite advances in understanding of language systems and functional neuroplasticity after brain injury, accurate predictors of aphasia recovery after stroke remain elusive. In order to better understand, predict, and enhance language improvement after stroke, there is a critical need to develop tools that can assess the influence of neuroplasticity on recovery.

Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation tool that has been used to predict the brain's neuroplastic capacity by assessing physiological responses observed immediately following administration of TMS. Additionally, difference in the physiological response to TMS have been shown to be affected by polymorphism in the gene coding for brain derived neurotrophic factor (BDNF). The current project explores the idea that because neural mechanisms of plasticity are essential determinants of both recovery after brain injury and physiologic response to TMS, magnetic brain stimulation could be employed as an indicator of the capacity for clinically relevant neuroplasticity, and potentially as a predictor of recovery from post-stroke deﬁcits such as aphasia

The goals of this protocol are to 1) explore the utility of theta burst stimulation (TBS), a type of transcranial magnetic stimulation (TMS), as a tool for assessing neuroplasticity in the language system in patients with aphasia due to stroke, 2) and to assess the utility of TBS as a biomarker and predictor of functional recovery in patients with aphasia.

This protocol will encompass two separate but related experiments. In the ﬁrst experiment, the investigators will apply TBS to brain regions that control language functions in aphasic patients in order to determine whether we can induce a transient improvement in naming ability. They will use a statistical model they have developed to categorize patients as either having High Plasticity or Low Plasticity. The investigators will determine whether this distinction predicts which patients are likely to have greater TBS-induced changes in language performance. In the second experiment, in the same patients, the investigators will apply TBS to the motor cortex to elicit changes in motor evoked potentials (MEPs). Using the same model to form matched groups, we predict that MEPs will be more attenuated in High Plasticity groups compared to the Low Plasticity group.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Transient TBS-induced changes in motor evoked potentials (MEPs)
timeFrame: Up to 2 week
measure: Transient TBS-induced changes in language performance
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Safety and Tolerability of TBS in patient with aphasia
timeFrame: Through study completion
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Neurology
name: Roy H Hamilton, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: