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TMS as a Biological Marker of Neuroplasticity

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ClinicalTrials.gov Identifier: NCT02867670
Recruitment Status : Active, not recruiting
First Posted : August 16, 2016
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date June 3, 2016
First Posted Date August 16, 2016
Last Update Posted Date July 4, 2019
Study Start Date July 2013
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 11, 2016)
  • Transient TBS-induced changes in motor evoked potentials (MEPs) [ Time Frame: Up to 2 week ]
    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.
  • Transient TBS-induced changes in language performance [ Time Frame: Up to 4 weeks ]
    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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02867670 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 11, 2016)
Safety and Tolerability of TBS in patient with aphasia [ Time Frame: Through study completion ]
We will collect the number of patients with TMS-related adverse events.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title TMS as a Biological Marker of Neuroplasticity
Official Title TMS as a Biological Marker of Neuroplasticity
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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

Saliva samples are optional.

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.
Condition
  • Stroke
  • Aphasia
Intervention Device: Transcranial Magnetic Stimulation
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.
Other Name: TMS
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Device: Transcranial Magnetic Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: August 11, 2016)
75
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02867670
Other Study ID Numbers 818784
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators Not Provided
Investigators
Principal Investigator: Roy H Hamilton, MD, MS Neurology
PRS Account University of Pennsylvania
Verification Date July 2019