The TrustTSC study is exploring whether treatment with an investigational medication (ganaxolone) has the potential to reduce the frequency of seizures associated with TSC in children and adults.
Currently, there are a limited number of treatments approved specifically for individuals living with tuberous sclerosis complex (TSC). Antiseizure medicines that are available to treat seizures associated with TSC may not work for everyone, may stop working over time, or may have to be stopped because of side effects.
If you or your child have been diagnosed with TSC and have inadequate response to your existing regimen for seizure control, there may be a clinical study for you.
The TSC Biosample Repository stores samples of blood, DNA, and tissues from individuals affected by TSC that scientists can use in their research. The samples we collect are linked to clinical data in the TSC Natural History Database. These samples and linked clinical data help researchers conduct experiments to find biomarkers of TSC, test potential drug treatments, and determine why TSC is so different from person to person.
Implemented in 2006, the TSC Natural History Database captures clinical data to document the impact of the disease on a person’s health over his or her lifetime. More than 2,000 people with TSC are enrolled in the project across 18 U.S.-based clinical sites and the TSC Alliance. The TSC Alliance provides funding to participating clinics to perform data entry, monitors the integrity of the database, and makes data available to investigators to answer specific research questions and identify potential participants for clinical trials and studies.
Description: Study design is a Phase IIb prospective multi-center, randomized, placebo-controlled, double-blind clinical trial. The goal will be to enroll 80 infants with Tuberous Sclerosis Complex who are less than 6 months of age prior to the onset of their first seizure.
Some of the listings above may be sponsored content. All listings will pertain to some part of the Seizure Tracker™ population. Feel free to reach out to us if you think there is a research study that should be featured here.
10 Search Results
All studies below are either currently recruiting or will be soon.
Epilepsy Prevalence and Intervention Study in Zhejiang Province, China
Brief Summary:
To carry out the epidemiological investigation on epilepsy in Zhejiang Province, China, and
then establish early comprehensive intervention to help patients with epilepsy to improve
seizure control and the quality of life.
Start Date: September 13, 2013
Close Date: December 31, 2022
Interventions:
Behavioral: education on epilepsy
Drug: routine and proper antiepileptic drugs
Association of Brain Derived Neurotrophic Factor (BDNF) rs6265 Gene Polymorphism With Susceptibility to Epilepsy
Brief Summary:
Epilepsy is a common neurological condition that affects people of all ages.Recent studies
found that epilepsy is associated with several chromosomal regions, where mutations in these
regions cause neurological dysfunction.
BDNF which is the most ample neurotropic factor in the CNS, has survival and growth promoting
roles in a variety of neurons. It has been shown to promote excitatory (glutamatergic)
synapses while weakening inhibitory (GABAergic) ones.
A nonsynonymous G to A single-nucleotide polymorphism (SNP) exists at position 196 of exon 2
(rs6265), which results in valine (val) to methionine (met) substitution. This polymorphism
affects intracellular packaging of pro-BDNF, its axonal transport and in turn,
activity-dependent secretion of BDNF at the synapse.
Start Date: November 1, 2021
Close Date: December 1, 2022
Interventions:
Genetic: Genotyping by Real Time PCR
Objective EEG Bed Side Assessment of Impaired Conscious Awareness in Epilepsy
Brief Summary:
In this project EEG recordings between healthy participants and those with a diagnosed
Absence-epilepsy will be compared. The investigators suggest differences in EEG microstate
analysis and neuropsychological parameters related to interictal cognitive impairment in
these patients. This projects goal is to derive an EEG-based measure of conscious awareness.
Start Date: October 1, 2021
Close Date: June 2024
Self-management for People With Epilepsy
Brief Summary:
SMART is a program for adult individuals with sub-optimally controlled epilepsy. It involves
educational and behavioral interventions intended to enhance epilepsy self-management.
The initial group session is in-person where individuals receive curriculum materials and
learn to utilize the Web format (such as Adobe Connect or ZOOM) and a teleconferencing
service needed to access the remainder of the group sessions. These sessions are held over an
8 week time period and are co-lead by a trained nurse educator and a trained peer educator.
The peer educator is someone with epilepsy and a history of NHEs. Educators use a written
curriculum delivered online, and the interactive sessions last 60-90 minutes. Groups are
limited to about 6 -12 adult participants.
After the group sessions are done, individuals have 8 telephone maintenance sessions with the
nurse educator and the peer educator spaced approximately 2 weeks apart.
SMART is intended for adults with epilepsy, especially those who belong to disadvantaged sub
groups such as rural populations, veterans with epilepsy and those who are underinsured.
People with epilepsy who belong to disadvantaged sub-groups are more likely to have poor
outcomes and often end up using expensive crisis-oriented care, and thus potentially might
benefit the most from self-management programs if they can be actively engaged.
Start Date: May 19, 2021
Close Date: December 2024
Interventions:
Behavioral: SMART 2
Evaluation of Memory and Forgetting in Patients With Epilepsy
Brief Summary:
Drug-resistant focal epilepsy (DRFE) is frequently associated with complications of varying
severity that impair patient's quality of life. Among these complications, cognitive
disturbances and especially episodic memory difficulties, play a determinant part. Episodic
memory can be defined as a function that allows the mental reconstruction of a past life
episode, through complex associative mechanisms that link the vivid experience to its context
of occurrence, called encoding context. It is a dynamic cognitive function, which calls on a
widely distributed cerebral network, mainly involving the medial temporal lobe, particularly
the hippocampus. Epilepsy could have a specific impact on this crucial network, disrupting
the binding mechanisms between the experienced events and their encoding context, which are
essential for efficient memory. Although patients with DRFE frequently demonstrate memory
impairment as assessed by standardised neuropsychological tests, it only imperfectly reflects
their difficulties. As a matter of fact, despite a subjective memory complaint, about 20%
have no memory impairment on these tests, resulting from a phenomenon called accelerated
long-term forgetting (ALF). ALF is indeed characterised by normal performance on standardised
neuropsychological tests involving retention delays of 20-30 minutes, but disabling memory
complaint and abnormally marked forgetting within hours or days that follow the learning
period. This phenomenon is widely described at the conceptual level, but remains difficult to
measure in daily practice, at least partly due to methodological limits. Thus, the validated
tools available in clinical routine are poorly adapted to the complexity and the associative
dimension of memory networks. There is therefore a clinical need for a specific assessment
tool that would be able to detect ALF, in order to better quantify it and to enable the
appropriate care of patients suffering from DRFE. The aim of the EPIMNESIE study is to
evaluate the diagnostic capacity of a behavioural associative memory task, based on the
analysis of encoding and consolidation mechanisms, in order to measure ALF. In this
prospective study, 40 patients with DRFE and 40 healthy subjects will be proposed to complete
a new associative memory task involving a learning phase and two recall sessions which will
take place at 30 minutes and 72 hours after the learning phase.
Start Date: January 26, 2022
Close Date: January 1, 2024
Interventions:
Diagnostic Test: Computerised associative memory task using abstract words and landscape photographs
Pulvinar Stimulation in Epilepsy: a Pilot Study
Brief Summary:
Deep brain stimulation (DBS) is one of the neuromodulation techniques that can be indicated
in patients suffering from refractory epilepsies, especially when an open resection has
failed or is not indicated, and vagal nerve stimulation (VNS) demonstrated no efficacy.
Benefits such as reduction of seizure frequency have been shown for thalamic stimulation of
the anterior thalamic nucleus (ANT), however it has limited efficacy and non-optimal
neurocognitive outcome, making the search for other targets crucial in this context. We
propose a novel target for DBS stimulation in drug-resistant epilepsy namely the medial
pulvinar thalamic nucleus (PuM).
This target has been chosen based on previous retrospective studies demonstrating that PuM is
involved during focal seizures and in loss of consciousness and seizure termination. PuM
stimulation also showed potential encouraging results based on the feasibility and safetu
studies recently published.
The main objective is to obtain a significant percentage of seizure reduction after 12 months
of PuM stimulation compared to baseline period. Quality of life and the relationship with
psychiatric and cognitive comorbidities will also be assessed.
Start Date: January 15, 2021
Close Date: January 15, 2025
Interventions:
Device: Pulvinar deep brain stimulation
Effectiveness of an Epilepsy Application for Self-management in Viet Nam
Brief Summary:
Epilepsy is a common neurological disease which effects all genders, ages and geographic
regions. Self-management refers to "the ability of the individual, in conjunction with
family, community, and healthcare professionals, to manage symptoms, treatments, lifestyle
changes, and psychosocial, cultural, and spiritual consequences of health conditions".
Optimal self-management may improve self-efficacy, knowledge about epilepsy of people with
epilepsy (PWE) and family, medical compliance and avoidance of seizure triggers. This study
aims to determine the effectiveness of the epilepsy app for PWE to improve self-management
Start Date: August 2022
Close Date: June 2024
Interventions:
Other: Epilepsy application
Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?
Brief Summary:
The purpose of this study is to evaluate standard of care exercise education alone or in
combination with a wearable physical activity tracker in people with epilepsy (PWE) to
determine the most effective way to increase physical activity and measure impact on
depression, anxiety, quality of life, sleep, and seizure frequency.
Start Date: June 16, 2020
Close Date: June 16, 2022
Interventions:
Behavioral: Activity Tracker Group
Behavioral: Standard of Care Group
Prospective Regional Epilepsy Database
Brief Summary:
PREDICT is an observational study following adults with an unprovoked seizure or epilepsy in
the health care region of western Sweden. The objective is to identify biomarkers and/or
genetic predisposition of relevance for diagnosis and/or treatment of epilepsy and study the
long-term prognosis and consequences of epilepsy.
Start Date: December 15, 2020
Close Date: December 31, 2031
Interventions:
Other: Seizure status
Diagnostic Test: Tests
Other: Epilepsy
Other: Demographics and psychosocial
Other: Health care
Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy: A Case Study
Brief Summary:
Out of 30,000 new cases per year in France, 30% of epileptic patients are drug-resistant.
Neurosurgery, which consists in resecting the epileptogenic zone, is the only chance of cure.
In the case of temporal epilepsy of the language-dominant hemisphere (TLE), this procedure
presents a high risk of increasing cognitive difficulties and may even be contraindicated for
this reason alone. The difficulties found are impairments in lexical access (anomia) and
verbal memory and affect more than 60% of patients. Preoperative cognitive rehabilitation
could influence brain plasticity mechanisms but there are currently no recommendations on
this topic. In this context, a speech rehabilitation procedure specific to the needs of ELTPR
patients was developed. Investigators rely on cognitive hypotheses explaining the disorders
but also on models of rehabilitation-induced neural plasticity likely to improve cognitive
reserve before surgery. Investigators hypothesize that preoperative cognitive language
rehabilitation in ELTPR patients may decrease surgical risk and improve postoperative
language prognosis.
The main objective is to demonstrate the efficacy of preoperative speech therapy on language
performance and to evaluate possible protective effects on postoperative language prognosis.
Single case study following the Single Case Experimental Design (SCED) methodology involving
the prior definition of the following elements: a repeated measure of the target behavior
(naming abilities), the sequential introduction of an intervention (speech therapy), whose
effect will be evaluated according to SCED specific analysis and statistics (visual analysis,
Tau -U, randomized tests).
Investigators expect patients' naming performance to be stable before the introduction of
speech therapy. It is expected that patients will progress in the trained words from the
beginning of speech therapy. Finally, in the postoperative period, investigators predict that
for the trained words, patients will show performances superior or equal to the
pre-rehabilitation period. This result would support a protective effect of preoperative
speech therapy.