Essential TremorNCT03025529
Transcranial Stimulation for Essential Tremor
A study testing Transcranial Magnetic Stimulation in people with Essential Tremor, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The main purpose of this study is to see if transcranial magnetic stimulation (TMS) can be used to help study brain function in healthy people and in those with neurological diseases like essential tremor. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 28 Nov 2016
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatients with essential tremor as diagnosed and confirmed by movement disorder specialist
- Women of child-bearing potential must provide a negative pregnancy test at entry into the study
- Stable doses of all medications for at least 14 days prior to study entry and for the duration of the study,
- At least a 1cm amplitude tremor as judged by the screener using a ruler
- Healthy subjects without tremor and without significant neurologic disease suggestive of cerebellar ataxia or other neurodegenerative diseases
- Ages 18-80
Who cannot join
- Any unstable illness or concomitant medical condition that, in the investigator's opinion, precludes participation in this study, including disorders that may affect gait or balance (i.e., stroke, arthritis, etc).
- Pregnancy or lactation.
- Concurrent participation in another clinical study.
- Dementia or other psychiatric illness that prevents the patient from giving informed consent (Montreal Cognitive Assessment Score score less than or equal to 21).
- Legal incapacity or limited legal capacity.
- Tremor derived from any cause other than essential tremor (Parkinson's disease, drug-induced, anxiety-induced) in the clinical assessment at screening
Show all 17Show fewer
- Currently taking lithium or amiodarone or any other drug judged to be contributing to tremor as judged by the investigator (may be a cause of tremor)
- No medication is an absolute exclusion from TMS. Medications will be reviewed by the responsible MD and a decision about inclusion will be made based on the following:
- The patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other Central Nervous System active drugs.
- The published TMS guidelines review of medications to be considered with TMS
- History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgement of the investigator
- TMS and MRI-Specific exclusion criteria including:
- Known metal in the head (such as a surgical aneurysm clip) or a history of prior neurosurgical procedures.
- Ferromagnetic bioimplants activated by any electronic, mechanical or magnetic means, such as cochlear implants, pacemakers, medication pumps, vagal stimulators, deep brain stimulators, neurostimulators, biostimulators, or ventriculo-peritoneal shunts.
- Subjects who have or might have bullet fragments or other shrapnel (veterans or workers exposed to metal in their work environment).
- Subjects with metallic paint (e.g. color contact lenses, tattoos, metallic eyeliner)
- Subjects expressing significant claustrophobia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The main purpose of this study is to see if transcranial magnetic stimulation (TMS) can be used to help study brain function in healthy people and in those with neurological diseases like essential tremor. This portion of the study is being done to establish the optimal methods for stimulating the brain to measure its responses.
Read the detailed description
Essential tremor (ET) is a movement disorder characterized by tremor of both hands, and often head and voice, affecting approximately 4.8-6.7 million individuals over the age of 40 in the United States alone. Hand tremor can limit basic activities of daily living like feeding, drinking, writing and dressing. While medications can be effective for tremor, they are often poorly tolerated due to their sedative or neuronal activity depressant properties. Surgical options such as deep brain stimulation of the ventral intermedius thalamus (Vim DBS) can be highly effective but its invasive nature limits its popularity. Noninvasive brain stimulation has demonstrated the ability to reduce tremor but precisely where to target brain stimulation to achieve the best results is currently unknown.
Repetitive transcranial magnetic stimulation (rTMS) enables noninvasive, selective and sustained modulation of specific neural networks, and can lead to clinical benefits in debilitating neurologic and psychiatric disorders, including medication-resistant depression, paresis following stroke or traumatic brain injury, Parkinson's disease, or dementia. There is also recent evidence that rTMS of the cerebellum can relieve hand tremor due to essential tremor. TMS uses electromagnetic induction to generate controlled currents in targeted brain structures that can be identified and defined using MRI-based neuronavigation. TMS is safe if appropriate guidelines are adhered to. To date, the impact of rTMS on ET has not been sufficiently established, but pilot studies offer promising results.
The investigators are testing whether MRI-guided neuronavigated cerebellar paired pulse TMS demonstrates abnormal physiologic measures in ET subjects compared to controls and whether there is reduction of tremor via cerebellar rTMS in patients with ET. The investigators plan to collect imaging, functional and neurophysiological assessments before and after the rTMS to identify the mechanistic underpinnings of rTMS-induced changes in tremor and cerebello-cortical inhibition.
- Conditions
- Essential Tremor
- Being tested
- Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Also called TMS
Transcranial Magnetic Stimulation or TMS is a noninvasive procedure (meaning it does not enter the body) that is used to stimulate a part of the brain using a magnetic field. This magnetic field can pass through the head safely and painlessly. TMS can be used to change activity in the brain.
Sham Transcranial Magnetic StimulationDevice
Also called Sham TMS
Sham Transcranial Magnetic Stimulation or sham TMS is like active TMS, a noninvasive procedure (meaning it does not enter the body) that is used to stimulate a part of the brain using a magnetic field. TMS can be used to change activity in the brain but in this intervention, the coil will be angled 90 degrees from the scalp, resting on one wing of the coil, and therefore will not be delivering active TMS.
| Study group | Role | What they receive |
|---|---|---|
| Active Cerebellar rTMS | Experimental | Cerebellar rTMS will be carried out in ET subjects using a MagPro stimulator with a double cone coil at 1Hz (1 pulse every second) for 3 minutes on the left and 3 minutes on the right, at the cerebellar location indicated by resting state functional connectivity MRI analysis. Subjects with ET will undergo 5 consecutive daily sessions of cerebellar rTMS at either the connectivity map generated target or sham rTMS and then crossover to the other target after 2 weeks. Subjects will be blinded to the treatment order assignment. The intensity of the stimulation will be determined as 90% of the resting motor threshold, to be determined at the beginning of the first visit. Receives: Device: Transcranial Magnetic Stimulation |
| Sham Cerebellar rTMS | Sham comparator | In sham rTMS, the same parameters and procedures as Treatment Procedures 4-8 will be used, except that the coil will be angled 90 degrees from the scalp, resting on one wing of the coil. Receives: Device: Sham Transcranial Magnetic Stimulation |
| Healthy control pilot | No intervention | This pilot phase is done to assess feasibility of obtaining MRI and cerebellocortical inhibition measures in healthy control subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor Reduction
tremor rating scale with questions regarding impact of tremor on activities of daily living and an physician-rated assessment of degree of tremor in hands, head, voice, and while drawing and writing
Measured: One week after intervention
Secondary outcomes (1)
Cerebellocortical Inhibition
Ratio of conditioned to unconditioned motor evoked potentials
Measured: One week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startFeb 2015
- Primary completion28 Nov 2016
- Study completion28 Nov 2016
Why it stopped: Investigator leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a crossover design with two groups, preceded by a separate single group of healthy controls in a pilot study to assess feasibility of obtaining the cerebellocortical inhibition measure
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ludy Shih, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025529
- Sponsor's protocol ID
- 2015P000011
- Status last verified
- Dec 2017
- First submitted
- 6 Jan 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Stimulation for Essential Tremor
- ClinicalTrials.gov ID
- NCT03025529
- Acronym / sponsor ID
- 2015P000011
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator leaving institution
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 28 Nov 2016 (actual)
- Study completion
- 28 Nov 2016 (actual)
- First posted
- 19 Jan 2017 (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.
The main purpose of this study is to see if transcranial magnetic stimulation (TMS) can be used to help study brain function in healthy people and in those with neurological diseases like essential tremor. This portion of the study is being done to establish the optimal methods for stimulating the brain to measure its responses.
Detailed description
Essential tremor (ET) is a movement disorder characterized by tremor of both hands, and often head and voice, affecting approximately 4.8-6.7 million individuals over the age of 40 in the United States alone. Hand tremor can limit basic activities of daily living like feeding, drinking, writing and dressing. While medications can be effective for tremor, they are often poorly tolerated due to their sedative or neuronal activity depressant properties. Surgical options such as deep brain stimulation of the ventral intermedius thalamus (Vim DBS) can be highly effective but its invasive nature limits its popularity. Noninvasive brain stimulation has demonstrated the ability to reduce tremor but precisely where to target brain stimulation to achieve the best results is currently unknown.
Repetitive transcranial magnetic stimulation (rTMS) enables noninvasive, selective and sustained modulation of specific neural networks, and can lead to clinical benefits in debilitating neurologic and psychiatric disorders, including medication-resistant depression, paresis following stroke or traumatic brain injury, Parkinson's disease, or dementia. There is also recent evidence that rTMS of the cerebellum can relieve hand tremor due to essential tremor. TMS uses electromagnetic induction to generate controlled currents in targeted brain structures that can be identified and defined using MRI-based neuronavigation. TMS is safe if appropriate guidelines are adhered to. To date, the impact of rTMS on ET has not been sufficiently established, but pilot studies offer promising results.
The investigators are testing whether MRI-guided neuronavigated cerebellar paired pulse TMS demonstrates abnormal physiologic measures in ET subjects compared to controls and whether there is reduction of tremor via cerebellar rTMS in patients with ET. The investigators plan to collect imaging, functional and neurophysiological assessments before and after the rTMS to identify the mechanistic underpinnings of rTMS-induced changes in tremor and cerebello-cortical inhibition.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a crossover design with two groups, preceded by a separate single group of healthy controls in a pilot study to assess feasibility of obtaining the cerebellocortical inhibition measure
| Arm | Type | Receives |
|---|---|---|
| Active Cerebellar rTMS | Experimental | Device: Transcranial Magnetic StimulationCerebellar rTMS will be carried out in ET subjects using a MagPro stimulator with a double cone coil at 1Hz (1 pulse every second) for 3 minutes on the left and 3 minutes on the right, at the cerebellar location indicated by resting state functional connectivity MRI analysis. Subjects with ET will undergo 5 consecutive daily sessions of cerebellar rTMS at either the connectivity map generated target or sham rTMS and then crossover to the other target after 2 weeks. Subjects will be blinded to the treatment order assignment. The intensity of the stimulation will be determined as 90% of the resting motor threshold, to be determined at the beginning of the first visit. |
| Sham Cerebellar rTMS | Sham comparator | Device: Sham Transcranial Magnetic StimulationIn sham rTMS, the same parameters and procedures as Treatment Procedures 4-8 will be used, except that the coil will be angled 90 degrees from the scalp, resting on one wing of the coil. |
| Healthy control pilot | No intervention | –This pilot phase is done to assess feasibility of obtaining MRI and cerebellocortical inhibition measures in healthy control subjects. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Outpatients with essential tremor as diagnosed and confirmed by movement disorder specialist
- Women of child-bearing potential must provide a negative pregnancy test at entry into the study
- Stable doses of all medications for at least 14 days prior to study entry and for the duration of the study,
- At least a 1cm amplitude tremor as judged by the screener using a ruler
- Healthy subjects without tremor and without significant neurologic disease suggestive of cerebellar ataxia or other neurodegenerative diseases
Key exclusion criteria (17 listed)
- Any unstable illness or concomitant medical condition that, in the investigator's opinion, precludes participation in this study, including disorders that may affect gait or balance (i.e., stroke, arthritis, etc).
- Pregnancy or lactation.
- Concurrent participation in another clinical study.
- Dementia or other psychiatric illness that prevents the patient from giving informed consent (Montreal Cognitive Assessment Score score less than or equal to 21).
- Legal incapacity or limited legal capacity.
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 |
|---|---|---|
| Transcranial Magnetic StimulationAlso: TMSTranscranial Magnetic Stimulation or TMS is a noninvasive procedure (meaning it does not enter the body) that is used to stimulate a part of the brain using a magnetic field. This magnetic field can pass through the head safely and painlessly. TMS can be used to change activity in the brain. | Device | Active Cerebellar rTMS |
| Sham Transcranial Magnetic StimulationAlso: Sham TMSSham Transcranial Magnetic Stimulation or sham TMS is like active TMS, a noninvasive procedure (meaning it does not enter the body) that is used to stimulate a part of the brain using a magnetic field. TMS can be used to change activity in the brain but in this intervention, the coil will be angled 90 degrees from the scalp, resting on one wing of the coil, and therefore will not be delivering active TMS. | Device | Sham Cerebellar rTMS |
Primary outcome
Tremor Reduction
Time frame: One week after intervention
tremor rating scale with questions regarding impact of tremor on activities of daily living and an physician-rated assessment of degree of tremor in hands, head, voice, and while drawing and writing
1 secondary outcome
Cerebellocortical Inhibition
Time frame: One week after intervention
Results and safety
The study was stopped early (reason given: Investigator leaving institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
Related trials for Essential Tremor
RecruitingPhase 2
Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor
Upper Limb Essential Tremor
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
RecruitingObservational study
Phenotype/Genotype Correlations in Movement Disorders
Movement Disorder
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
RecruitingPhase 2
Stereotactic Radiosurgery in the Treatment of Essential Tremor
Essential Tremor
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Essential Tremor, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 17 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: stopped early, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 stopped early (reason given: Investigator leaving institution). Results are not available in the source record.
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?
Tremor Reduction (time frame: One week after intervention). 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 19 Dec 2017.