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Participate in Clinical Trials

If you are interested in participating in our research or clinical trials across our affiliated centers please read the information below:

 

The University of Pennsylvania Center for Brain Science, Translation, Innovation, and Modulation (brainSTIM) is looking for participants to study the effects of neuromodulation through the use of technologies including Transcranial Magnetic Stimulation (TMS), Transcranial Electrical Stimulation (tES), structural and functional magnetic resources imaging (MRI & fMRI), electroencephalography and electromyography (EEG & EMG), and diffuse optical spectroscopy (DOS) and diffuse correlation spectroscopy (DCS).

To learn more about each technology and how they are used, click here.

To view our Clinical Participation form, scroll down.

To learn more about current trials being conducted at brainSTIM and our affiliated centers, scroll down.



Current Trials

Title: A Pilot Study to Evaluate the Effect of CT1812 Treatment on A-beta Oligomer Displacement into CSF in Subjects with Mild to Moderate Alzheimer's Disease

PI: Yvette Sheline

Other: N/A

Description:  Cognition Therapeutics is developing an oral formulation of CT1812 to treat AD and mild cognitive impairment. This is a multi-center, Phase 1b, randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to moderate AD, sponsored by the NIH. The primary purpose of this study is to evaluate target engagement of CT1812 treatment by measuring the displacement of AB oligomers into cerebrospinal fluid (CSF). Target population is 50-85 year olds with mild to moderate Alzheimers Disease Dementia; must be able to provide own consent and must have a caregiver willing to accompany to all visits. Subjects will be randomized in a 2:1 (active:placebo) ratio and admitted inpatient (CTRC) for a Confinement Visit that will take place over 2 days, consisting of four phases: admission, 24-hour CSF and plasma sampling, 6-hour period of observation, and discharge. Participants will have CSF and plasma sampling for 3 hours prior to drug administration and then for 24 hours post-drug administration. Up to 18 subjects will be enrolled; interim analyses will be conducted after first 6 and next 6 to assess dosage of CT1812 and to determine if there is sufficient evidence of oligomer displacement to continue full trial with all 18 subjects.

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Title: Novel neural circuit biomarkers of major depression response to computer-augmented CBT (1R01MH110939 - 01A1)

PI: Yvette Sheline

Other: N/A

Description: This is a trial of an FDA-approved treatment for Major Depressive Disorder (MDD), computer-augmented cognitive behavioral therapy (CCBT), to examine novel potential neural circuit biomarkers of treatment response rather than to test efficacy. We will enroll 60 subjects, 18-60 years, who are seeking treatment for a current episode of Major Depressive Disorder. We also will enroll 40 healthy controls of a similar age/sex distribution. MDD subjects will be scheduled to receive CCBT at the first available appointment; all will be scheduled within 4 weeks. All subjects will have an fMRI at baseline; MDD subjects will have an fMRI after treatment. MDD subjects scheduled to start CCBT treatment after 3 weeks will complete an additional fMRI before they begin CCBT.

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Title: Transcranial Magnetic Stimulation Exploration of Motor Cortex Functional Anatomy

PI: Branch Coslett

Other: N/A

Description: The purpose of the proposed study is to explore the nature of the codes that are present in the primary motor cortex. All complex actions involves the contraction of multiple muscles, the timing and intensity of which is precisely modulated. The traditional view of this process is that an abstract representation of the action is coded in the posterior parietal lobe and this code informs premotor cortex which in turn contacts the primary motor cortex; crucially, on most accounts the primary motor cortex is "assigned to" a specific muscle such that when that neuronal population is stimulated a single muscle contraction is generated. An alternative account supported by recent studies involving primates and limited data from humans is that the primary motor cortex codes actions such as clenching the fingers that are generated by multiple muscles. We plan to address this question by stimulating primary motor cortex at multiple locations with Transcranial Magnetic Stimulation of the primary motor cortex and recording simultaneously from 6 muscles using surface electromyography.

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Title: A Pilot Study of Network-Guided Transcranial Magnetic Stimulation for Adult ADHD (Learn More)

PI: John Medaglia

Other: N/A

Description: Attention Deficit Hyperactivity Disorder (ADHD) is characterized by symptoms of impulsivity, inattention, and hyperactivity that emerge in childhood and frequently persist into adulthood. These symptoms are accompanied by deficits in cognitive control and risky decision making that can lead to negative psychosocial and health-related outcomes. With advances in the neuroimaging field, we are learning where and how self-control over decisions and behaviors is executed in the brain. This work points to the central role of neural activity in the dorsolateral prefrontal cortices (DLPFC) in self-control processes that contribute to healthy choices. Further, emerging evidence shows that activity in the prefrontal cortices and cognitive control circuits can be modulated using a noninvasive and safe intervention: repetitive transcranial magnetic stimulation (TMS). Neuroimaging reveals that different subjects have distinct functional network organization even when brain anatomy looks similar between individuals. This within-subject proof of concept study will investigate whether TMS administered to two different networks thought to be involved in executive functions and attention can enhance specific functions in subjects with ADHD.

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Title: Mini Theta Burst TMS to Promote Brain Plasticity Indexed by fMRI

PI: Desmond Oathes

Other: N/A

Description: Non-invasive transcranial magnetic stimulation (TMS) is now FDA-approved for the treatment of major depressive disorder (MDD). However, there is growing evidence that the targeting strategy for delivering TMS treatment would yield superior clinical outcomes if it were more tailored to individual neuroanatomy. In this study, we plan to examine whether functional MRI-guided TMS might be more effective than traditional methods at temporarily influencing neural circuit communication. If this is true, future studies may utilize these methods to yield an even greater leap forward in promoting optimal clinical outcomes using full doses of TMS for treatment.

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Title: Network Control TMS fMRI

PI: Desmond Oathes

Other: N/A

Description: The University of Pennsylvania seeks young adults ages 18-28 for a research study. The purpose of this study is to use different types of MRI scans to find individualized TMS (transcranial magnetic stimulation) targets and compare how the brain responds. We are also interested in using TMS during a working memory test to see how it affects task performance. TMS involves a procedure during which your brain will be noninvasively (i.e. from the scalp) stimulated by magnetic pulses and MRI scans are used to take pictures of your brain. In this study we administer TMS inside of the MRI scanner so we can see how the stimulation affects the rest of the brain.

Eligibility Criteria:

  • 18-28 years old
  • Right-handed 
  • No history of schizophrenia or bipolar disorder
  • No history of neurological illness
  • Healthy participants: No history of any mental illness
  • ADD/ADHD participants: Diagnosed with ADD/ADHD
  • ADD/ADHD participants:  Ability to refrain from stimulant medication within 24 hours of study sessions

Participation Includes:

  •  Visit 1: Initial Screening Session (4-6 hours)
  • Visit 2: MRI Scan and Assessments (2-4 hours)
  • Visit 3: MRI Scan with TMS (1.5 hours)
  • Visit 4 (healthy control participants only): MRI Scan with TMS (1.5 hours)
  • Visit 5: Task MRI Scan (1 hour)
  • Monetary Compensation

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Title:  Network Control TMS/fMRI

PI: Theodore Satterthwaite 

Other: Gabriela Vogeley 

Description: The Center for Neuromodulation in Depression and Stress is recruiting healthy participants as well as those with ADD/ADHD for a TMS/fMRI study. Transcranial Magnetic Stimulation (TMS) involves a procedure during which your brain will be non-invasively (i.e. from the scalp) stimulated by magnetic pulses and MRI scans are used to take pictures of your brain. In this study we administer TMS inside of the MRI scanner so we can see how the stimulation affects the rest of the brain. How long will I be in the study? If you agree to take part in this study, your involvement will take place over approximately three weeks.

To schedule study visits, please first complete our online screening form here or contact the Center for Neuromodulation in Depression and Stress at 215-476-2637.

Eligibility Criteria:

  • 18-28 years old
  • right-handed
  • un-medicated or willing to stop stimulant medication 24 hours prior to each study visit
  • free of any neurological diseases
  • no metallic implants or other MRI contraindications
  • willing to try TMS.

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Title:  A Phase 2 Randomized Blinded study of Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for the treatment of Chronic Aphasia 

PI:   Branch Coslett

Other: Samuel Cason

Description: Patient's interested in participating will undergo a medical interview with a UPenn Neurologist to determine eligibility. Once enrolled patients will receive brain imaging (MRI), Transcranial Magnetic Stimulation (TMS), and speech therapy. TMS uses magnetic pulses to stimulate regions of the brain from outside the head, on the scalp. TMS can affect brain cells in specific locations of the brain. In this study, researchers will target language areas of the brain in an attempt to improve speech. This is a randomized trial, which means not all participants will receive real TMS. However, everyone in the study will have speech therapy.

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Title: Treatment of Communication Difficulties in Alzheimers’s Disease: A TMS and Speech Language Therapy Study.

PI: Branch Coslett

Other: Samuel Cason

Link: N/A

Description: The Laboratory for Cognition and Neural Stimulation (LCNS) at the University of Pennsylvania and the Penn Memory Center are partnering on a new study. We are interested in pairing non-invasive brain stimulation (TMS – Transcranial Magnetic Stimulation) with speech language therapy, to improve communication impairments in patients with mild to moderate Alzheimer’s Disease (AD). This study also aims to further understanding of how AD affects language systems in the brain.


Title: CILT+tDCS as a Potential Therapy for Primary Progressive Aphasia

PI: Roy Hamilton

Other: Chris Haslam, Leah Friedman

Link: N/A                                      

Description: Primary Progressive Aphasia, or PPA, is a condition that affects language abilities. Aperson with PPA may have difficulties speaking, understanding speech, reading or writing and these difficulties worsen over time.

The purpose of this study is to determine whether a form of non-invasive brain stimulation called Transcranial Direct Current Stimulation (or tDCS) can be used as a therapeutic technique in combination with Constraint-Induced Language Therapy (CILT) to improve the language symptoms of PPA.

tDCS use a mild electrical current about the same strength as a 9-volt battery to stimulate regions of the brain from outside the head. tDCS changes how responsive certain regions of the brain can be(i.e. more or less responsive). 

CILT is a form of speech therapy that focuses on improving speech production in everyday life. The therapy will change as you improve in order to make sure you have the best chance of increasing your language skills. This study will use tDCS combined with CILT to try to increase how responsive the language areas of the brain can be, in order to determine whether this type of stimulation can help enhance the benefits of CILT.

Who may be eligible to participate:

  • Ages 45-80 years old
  • Must have aphasia due to Primary Progressive Aphasia
  • Native English speaker

Participation:

  • Visit 1 – Enrollment & Screening
  • Visit 2 – Baseline MRI
  • Visit 3 & 4 Baseline Language Assessment
  • Visit 5 -14 – Therapy
  • Visit 16 – 18 – Immediate Follow-up
  • Visit 19 & 20 – 6 week Follow-up
  • Visit 21-24 – 12 week Follow-up

*****************CROSSOVER*****************

  • Visit 25 – Baseline Language Assessment
  • Visit 26-35 – Therapy
  • Visit 26-38 – Immediate Follow-up
  • Visit 39 & 40 – 6 week Follow-up
  • Visit 41-43 1- 12 week Follow-up