Comprehensive behavioral intervention for Syndrome

Phase-Based Estimates
1
Effectiveness
1
Safety
Fixel Neurologic Institute, Gainesville, FL
Syndrome+1 More
Comprehensive behavioral intervention - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Syndrome

Study Summary

This study is evaluating whether rTMS can improve tics in people with Tourette's Syndrome.

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Eligible Conditions

  • Syndrome
  • Tourette Syndrome

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Comprehensive behavioral intervention will improve 1 primary outcome and 11 secondary outcomes in patients with Syndrome. Measurement will happen over the course of Through study completion, an average of 3 months.

Baseline (T0), immediately after completion of rTMS (T1), immediately after completion of CBIT (T2), and approximately one month after completion of the intervention (rTMS + CBIT) (T3)
High Density Electroencephalography (EEG)
Month 3
Adult ADHD Self-Report Scale (ASRS)
Beck Anxiety Inventory (BAI)
Beck Depression Inventory (BDI)
Functional MRI (fMRI)
Gilles de la Tourette Syndrome - Quality of Life scale (GTS-QOL)
Modified Rush Videotape Tic Rating Scale (mRVTRS)
TMS measures: Cortical Silent Period (CSP)
TMS measures: Motor Evoked Potential (MEP)
TMS measures: Short Interval Intracortical Inhibition (SICI)
Tic severity
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Sham rTMS Group
Active rTMS Group
Placebo group

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Comprehensive Behavioral Intervention is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Active rTMS GroupPatients will be seated in a comfortable reclined chair. The neurostimulation protocol will include 1-Hz rTMS over the bilateral SMA at 110% resting motor threshold (RMT). The SMA will be identified as 4 cm anterior to the vertex (Cz in standard 10-20 EEG setup). Each session will consist of 6 trains lasting 5 minutes each (300 pulses per train) with an intertrain interval of 1 minute for a total duration of 35 minutes (1800 pulses). Patients will receive 4 sessions each day on 4 consecutive days for a total of 16 sessions. Daily duration of this study protocol should last approximately 170 minutes including a 10 minute break in between each session.
Sham rTMS GroupParticipants will undergo the same procedure for identifying target location and RMT used in patients receiving real rTMS. Simulated rTMS will be administered using a MagStim sham coil, which produces discharge noise and vibration without stimulating the cerebral cortex
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Magnetic Stimulation
2011
Completed Phase 4
~600

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (t0), immediately after completion of rtms (t1), immediately after completion of cbit (t2), and approximately one month after completion of the intervention (rtms + cbit) (t3)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline (t0), immediately after completion of rtms (t1), immediately after completion of cbit (t2), and approximately one month after completion of the intervention (rtms + cbit) (t3) for reporting.

Closest Location

Fixel Neurologic Institute - Gainesville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Any patient diagnosed with Tourette Syndrome > 18 years of age with moderate tic severity.
Participants will be allowed to continue oral medications that they are taking for TS concurrently but will not be allowed to change their concurrent medication regimen throughout the duration of the study

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can syndrome be cured?

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Each individual disease component in patients in the syndrome has different causes: this includes metabolic syndrome, lipid profile and lipid metabolism, thyroid dysfunction of the thyroid gland, vitamin deficiency, inflammation, nephritis or malignancy. For syndrome to be reversed, it is required to cure such disease components.

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What causes syndrome?

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There is some evidence that syndromes may be caused by a combination of certain characteristics in a person. For example, having the right combination of personality traits can cause people to get sick when others are well.\n\n- Mental disorder\n- Psychological trait"

"Fishing bait\n\nFishing bait is a type of artificial substance which is normally used to draw a fish into a fisher's net or a fish trap. Fishing bait is intended to simulate the natural foraging behaviour of a fish to attract fish. It is thus classified alongside fish lures as a form of artificial lure.

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What are the signs of syndrome?

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The sign of syndromic osteoporosis in adults, including the presence of fracture, and radix nigrabdominis syndrome, a common complication of osteoporosis, in females, may be the same disease. Furthermore, the use of a standard skeleton X-ray for the determination of bone density appears to be unreliable and should not be relied upon as a screening instrument for osteoporosis without the help of dual energy X-ray absorptiometry measurement.

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How many people get syndrome a year in the United States?

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There were a number of reasons for these results, but the main one was the lack of knowledge of some physicians and patients of Syndrome A in the past. Even though there were a lot of patients, clinicians and parents should be more aware of Syndrome A and its prevalence.

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What is syndrome?

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Syndrome can be used as a substitute for a clinical diagnosis, by creating a clinically useful and meaningful way to represent a range of conditions through the use of clinical terms. Syndromes offer an attractive alternative in the field of primary care and clinical epidemiology as they help to simplify and illustrate clinical problems.

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What are common treatments for syndrome?

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This classification of the syndromes into basic (basic developmental disorders) and syndromes with developmental delay (i.e. multiple disabilities of childhood) is useful in directing management and in the planning of services. It facilitates comparison and the identification of common trends in clinical practice.

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What is the latest research for syndrome?

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[The syndroma, which is an abbreviation of Syndrome, is the most recent article to be published about syndrome, published in January 2016. Please use Syndroma (www.withpower.com/syndroma) to access these articles.] To gain a better understanding about this syndrome, visit Syndromes.org, which has the most recent updated articles about syndromes.org. Syndromes.org offers patients a place to connect to other patients who match your symptoms. Syndromes.org's goal is not only to provide the latest information about syndromes, but to have patients meet other patients who are going through similar Syndromes.com, Syndromes.org, Syndromes.

Unverified Answer

Does syndrome run in families?

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There are two major genetic systems that produce susceptibility or resistance to rheumatic diseases. Aspects of these conditions appear to run in families as is frequently reported with other rheumatic diseases.

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What are the common side effects of comprehensive behavioral intervention?

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With a median follow-up time of 1.3 years, no evidence of sustained deleterious effects was found with respect to the frequency of moderate to severe symptoms of depression or anxiety in our sample.

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What are the latest developments in comprehensive behavioral intervention for therapeutic use?

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The new development in treatment research for substance-using individuals with a history of trauma-and-abuse needs to address four main themes: integrating cognitive-behavioral therapy into drug addiction treatment models; emphasizing trauma treatment as a core treatment approach; developing trauma-informed treatments that integrate cognitive-behavioral therapy with trauma psychotherapy; and incorporating trauma-informed trauma treatment approaches into clinical models of addiction treatment.

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Have there been other clinical trials involving comprehensive behavioral intervention?

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There have been few clinical studies employing comprehensive behavioral intervention for adolescent and adult smokers. Most of them were case-reports or summaries of earlier studies. Such studies failed to provide sufficient quality evidence for making a firm recommendation about the effects of comprehensive behavioral intervention on smoking behavior. At present, we recommend that this topic be included in the agenda of future multi-center clinical trials.

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Who should consider clinical trials for syndrome?

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There may be potential for significant advances in knowledge to be made based on syndrome. The identification of specific syndrome groups for which new therapies may be effective is of particular importance.

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