Transcranial Stimulation for Essential Tremor

NCT03025529 | Terminated

• 1 other identifier: 2015P000011
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. This portion of the study is being done to establish the optimal methods for stimulating the brain to measure its responses.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

• 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

  One week after intervention

Secondary Outcomes (1)

• Cerebellocortical Inhibition

  One week after intervention

Study Arms (3)

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.

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.

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.

Interventions

Transcranial Magnetic Stimulation DEVICE

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.

Also known as: TMS

Active Cerebellar rTMS

Sham Transcranial Magnetic Stimulation DEVICE

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.

Also known as: Sham TMS

Sham Cerebellar rTMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• 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
• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Essential Tremor

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In the single group pilot study, there is no intervention and no masking-- just obtaining an MRI and a cerebellocortical inhibition measure. There were 8 subjects in this phase of the study. There were no subjects enrolled in the crossover design phase of this study.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Model Details: 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

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 19, 2017
• Study Start: February 1, 2015
• Primary Completion: November 28, 2016
• Study Completion: November 28, 2016
• Last Updated: December 19, 2017

Record last verified: 2017-12

Locations

US (1)