Generalized Anxiety Disorder (GAD)NCT02708472
Safety and Efficacy of Synchronized Transcranial Magnetic Stimulation for the Treatment of Generalized Anxiety Disorder
A study testing synchronized Transcranial Magnetic Stimulation (sTMS) in people with Generalized Anxiety Disorder (GAD), run by University of Texas Southwestern Medical Center.
Trial summary
This clinical trial is an investigator-initiated open label study designed to evaluate the safety and efficacy of sTMS in subjects with Generalized Anxiety Disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder (GAD)
- What is being tested?
- synchronized Transcranial Magnetic Stimulation (sTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 22 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects will be 18 - 65 years of age.
- Primary Diagnosis of Generalized Anxiety Disorder (GAD) confirmed by structured interview using the Mini International Neuropsychiatric Interview (MINI), version 7, with minimum duration of current episode of 3 months
- Baseline Hamilton Anxiety (HAM-A) score equal or greater than 18
- The baseline EEG is of sufficient duration and quality that it can be processed for quantitative analysis.
- Taking less than or equal to 2 psychotropic medications at a stable dose for a minimum of 2 weeks to remain unchanged throughout duration of study.
- Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.
Who cannot join
- Subjects are unable or unwilling to give informed consent.
- Primary Diagnosis with the following conditions confirmed by MINI (current unless otherwise stated):
- GAD secondary to a general medical condition, or substance-induced.
- History of substance abuse or dependence within the past 6 months (except nicotine and caffeine).
- Major depressive disorder, bipolar disorder or psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes.
- Eating disorder (current or within the past year).
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- Obsessive compulsive disorder (lifetime).
- Post-traumatic stress disorder (current or within the past year).
- Attention Deficit Hyperactivity Disorder (ADHD) currently being treated.
- Subjects meeting criteria for Axis II cluster A or B diagnosis based upon Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria, which in the judgment of the Investigator may hinder the subjects in completing the procedures required by the study protocol.
- Subjects with a clinically defined neurological disorder including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure.
- Space occupying brain lesion.
- Any history of seizure EXCEPT those therapeutically induced by Electroconvulsive Therapy (ECT). Childhood febrile seizures are acceptable and these subjects may be included in the study.
- History of stroke.
- Transient ischemic attack within two years.
- Cerebral aneurysm.
- Dementia (Montreal Cognition Assessment score less than 23).
- Parkinson's disease.
- Huntington's disease.
- Multiple sclerosis.
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold.
- Subjects with any of the following treatment histories:
- TMS within 4 weeks prior to the screening visit or any prior treatment with sTMS
- ECT treatment within 1 year prior to the screening visit.
- Failure to respond to TMS or ECT treatment (i.e., consistent with Antidepressant Treatment History Form confidence level 3 or higher) in this or any previous episode.
- Lifetime history of treatment with Deep Brain Stimulation (DBS) or Vagus Nerve Stimulation (VNS).
- Use of any investigational drug or device within 6 months of the screening visit.
- Subjects are adequately benefiting from current antianxiety medication(s)
- Significant acute suicide risk as judged by the investigator
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
- Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed.
- Clinically significant abnormality or clinically significant unstable medical condition, as indicated by medical history, physical examination, ECG results, or clinical laboratory testing, that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results, e.g., any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning.
- Women who are currently pregnant or not using a medically acceptable means of birth control and women who are breastfeeding.
- Positive urine drug screen for illicit substances. (A positive urine drug screen at screening may be repeated once prior to randomization).
- Any condition which in the judgment of the Investigator would prevent the subject from completion of the study.
About this study
Official title: Safety and Efficacy of Synchronized Transcranial Magnetic Stimulation (sTMS) for the Treatment of Generalized Anxiety Disorder (GAD) -An Open Label Investigator Initiated Trial
This clinical trial is an investigator-initiated open label study designed to evaluate the safety and efficacy of sTMS in subjects with Generalized Anxiety Disorder.
Read the detailed description
Subjects will receive 5 daily treatments per treatment week for 4 weeks (20 treatments). Patients who do not meet a 50% reduction of Hamilton Anxiety Rating Scale (HAM-A) score (non-responders) at 4 weeks will be offered 2 additional treatment weeks for up to 30 treatments total.
Subjects who qualify for enrollment will be followed and assessed using the: Mini International Neuropsychiatric Interview (MINI) for Axis 1, Montreal Cognitive Assessment (MoCA), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D17), Generalized Anxiety Disorder 7-item (GAD-7), and Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR16) patient reported scale. Treatment will be initiated on Day 1 of the study and will be continued for a minimum of 4 and a maximum of 6 weeks.
- Conditions
- Generalized Anxiety Disorder (GAD)
- Being tested
- synchronized Transcranial Magnetic Stimulation (sTMS)
- Keywords
- Generalized Anxiety Disorder, synchronized Transcranial Magnetic Stimulation, Anxiety, Neurostimulation, TMS
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synchronized Transcranial Magnetic Stimulation (sTMS)Device
Subjects who qualify will receive daily active sTMS treatments with the NeoSync, Inc sTMS device. The device includes an EEG recording module and the device uses a proprietary algorithm to determine the individualized alpha frequency (IAF). The IAF obtained during this baseline recording is used throughout the study.
The device contains three magnets in the sagittal line above the subject's scalp, which rotate along a transverse axis. sTMS stimulation is delivered broadly over the prefrontal and frontal regions of the brain. These magnets rotate to generate a sinusoidal magnetic field set at precisely the average individualized alpha frequency (IAF). Each therapy session lasts 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Open-label | Experimental | Subjects who qualify will receive daily active synchronized Transcranial Magnetic Stimulation (sTMS) treatments. Treatment will be initiated on Day 1 of the study. Subjects will come to the clinic for 5 daily treatment sessions for a total of 4 treatment weeks (20 treatment sessions). Treatment will be discontinued at the end of Week 4. Subjects will be clinically evaluated for safety and efficacy at the end of each of the four weekly treatment courses.
At the end of Week 4, subjects who have not met the endpoint of 50% reduction in Hamilton Anxiety Rating Scale (HAM-A) score will be eligible to be considered for 2 additional weeks of daily treatment in an extended phase (for a total of 30 treatment sessions). Receives: Device: synchronized Transcranial Magnetic Stimulation (sTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in score on the Hamilton Anxiety Rating Scale (HAM-A)
Measured: Baseline to Week 4
Secondary outcomes (4)
Clinical response on the Hamilton Anxiety Rating Scale
Clinical response defined as greater than or equal to 50% reduction of assessment score
Measured: Baseline to Week 4
Clinical response on the Generalized Anxiety Disorder 7-item scale (GAD-7)
Clinical response defined as greater than or equal to 50% reduction of assessment score
Measured: Baseline to Week 4
Clinical response on the Hamilton Depression Rating Scale (HAM-D17)
Clinical response defined as greater than or equal to 50% reduction of assessment score
Measured: Baseline to Week 4
Clinical response on the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR16)
Clinical response defined as greater than or equal to 50% reduction of assessment score
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study start1 Apr 2016 (estimated)
- Primary completion1 Apr 2017 (estimated)
- Study completion22 Jan 2018 (estimated)
Why it stopped: This study never moved forward due to funding constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wave Neuroscience
- Responsible party
- Principal investigator, Mustafa Husain, University of Texas Southwestern Medical Center
- Investigators
- Mustafa M. Husain, M.D., Principal investigator, University of Texas Southwestern Medical CenterAhmad Raza, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708472
- Sponsor's protocol ID
- STU 112015-078
- Status last verified
- Aug 2018
- First submitted
- 10 Mar 2016
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Synchronized Transcranial Magnetic Stimulation (sTMS) for the Treatment of Generalized Anxiety Disorder (GAD) -An Open Label Investigator Initiated Trial
- ClinicalTrials.gov ID
- NCT02708472
- Acronym / sponsor ID
- STU 112015-078
- Conditions
- Generalized Anxiety Disorder (GAD)
- Keywords
- Generalized Anxiety Disorder, synchronized Transcranial Magnetic Stimulation, Anxiety, Neurostimulation, TMS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study never moved forward due to funding constraints.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Wave Neuroscience
- Study start
- 1 Apr 2016 (estimated)
- Primary completion
- 1 Apr 2017 (estimated)
- Study completion
- 22 Jan 2018 (estimated)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is an investigator-initiated open label study designed to evaluate the safety and efficacy of sTMS in subjects with Generalized Anxiety Disorder.
Detailed description
Subjects will receive 5 daily treatments per treatment week for 4 weeks (20 treatments). Patients who do not meet a 50% reduction of Hamilton Anxiety Rating Scale (HAM-A) score (non-responders) at 4 weeks will be offered 2 additional treatment weeks for up to 30 treatments total.
Subjects who qualify for enrollment will be followed and assessed using the: Mini International Neuropsychiatric Interview (MINI) for Axis 1, Montreal Cognitive Assessment (MoCA), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D17), Generalized Anxiety Disorder 7-item (GAD-7), and Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR16) patient reported scale. Treatment will be initiated on Day 1 of the study and will be continued for a minimum of 4 and a maximum of 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label | Experimental | Device: synchronized Transcranial Magnetic Stimulation (sTMS)Subjects who qualify will receive daily active synchronized Transcranial Magnetic Stimulation (sTMS) treatments. Treatment will be initiated on Day 1 of the study. Subjects will come to the clinic for 5 daily treatment sessions for a total of 4 treatment weeks (20 treatment sessions). Treatment will be discontinued at the end of Week 4. Subjects will be clinically evaluated for safety and efficacy at the end of each of the four weekly treatment courses. At the end of Week 4, subjects who have not met the endpoint of 50% reduction in Hamilton Anxiety Rating Scale (HAM-A) score will be eligible to be considered for 2 additional weeks of daily treatment in an extended phase (for a total of 30 treatment sessions). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All subjects will be 18 - 65 years of age.
- Primary Diagnosis of Generalized Anxiety Disorder (GAD) confirmed by structured interview using the Mini International Neuropsychiatric Interview (MINI), version 7, with minimum duration of current episode of 3 months
- Baseline Hamilton Anxiety (HAM-A) score equal or greater than 18
- The baseline EEG is of sufficient duration and quality that it can be processed for quantitative analysis.
- Taking less than or equal to 2 psychotropic medications at a stable dose for a minimum of 2 weeks to remain unchanged throughout duration of study.
Key exclusion criteria (36 listed)
- Subjects are unable or unwilling to give informed consent.
- Primary Diagnosis with the following conditions confirmed by MINI (current unless otherwise stated):
- Subjects meeting criteria for Axis II cluster A or B diagnosis based upon Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria, which in the judgment of the Investigator may hinder the subjects in completing the procedures required by the study protocol.
- Subjects with a clinically defined neurological disorder including, but not limited to:
- Subjects with any of the following treatment histories:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| synchronized Transcranial Magnetic Stimulation (sTMS)Subjects who qualify will receive daily active sTMS treatments with the NeoSync, Inc sTMS device. The device includes an EEG recording module and the device uses a proprietary algorithm to determine the individualized alpha frequency (IAF). The IAF obtained during this baseline recording is used throughout the study. The device contains three magnets in the sagittal line above the subject's scalp, which rotate along a transverse axis. sTMS stimulation is delivered broadly over the prefrontal and frontal regions of the brain. These magnets rotate to generate a sinusoidal magnetic field set at precisely the average individualized alpha frequency (IAF). Each therapy session lasts 30 minutes. | Device | Open-label |
Primary outcome
Mean change in score on the Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Baseline to Week 4
4 secondary outcomes
Clinical response on the Hamilton Anxiety Rating Scale
Time frame: Baseline to Week 4
Clinical response on the Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Baseline to Week 4
Clinical response on the Hamilton Depression Rating Scale (HAM-D17)
Time frame: Baseline to Week 4
Clinical response on the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR16)
Time frame: Baseline to Week 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa M. Husain, M.D. principal investigator
University of Texas Southwestern Medical Center
Ahmad Raza, M.D. principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing synchronized Transcranial Magnetic Stimulation (sTMS) in people with Generalized Anxiety Disorder (GAD), run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in score on the Hamilton Anxiety Rating Scale (HAM-A) (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.