Essential Tremor Clinical Trial
Official title:
Alternating Current Stimulation for Essential Tremor: a Pilot Study to Identify the Most Promising Strategy
Movement disorders are common neurological disorders, characterized by either excess or
paucity of movements. Essential tremor (ET) is one of the most common of these disorders,
defined as chronic, rhythmic involuntary movements (tremor) that occur primarily during
action involving the upper extremities as prominent body site. ET occurs in between 0.4% and
4% of adults below age 60, its prevalence and related impairment of routine daily actions
increasing dramatically with age. More than half of patients do not regain functional
independence with medications. These patients are offered functional neurosurgical approaches
that carry procedural risk or adverse effects secondary to deep electric stimulation of
surgical lesioning. Hence, there is a substantial need for alternative, non-invasive
therapeutic options for this disabling neurological disorder. Recently, non-invasive
neuromodulation applied as transcranial alternating current stimulation (tACS), has emerged
as promising for tremor control. In healthy subjects, tACS applied with a high definition (or
focused) montage to the primary motor cortex (M1), was found to entrain physiological tremor;
in patients with Parkinson's disease, tACS could decrease the amplitude of rest tremor when
the stimulation was delivered in phase with, and at the same frequency of, the tremor. Tremor
in ET could also be entrained applying ACS to the arm skin's peripheral nerves
(transcutaneous ACS), but its effect on tremor amplitude is unknown.
METHODS AND POTENTIAL CONTRIBUTION/IMPACT OF THE RESEARCH.
The proposed project aims to explore the whole potential of tACS for the tremor suppression
in ET. The investigators aim to test the following hypotheses:
1. focused (or high definition, HD) tACS delivered over M1 at the same frequency of the
tremor is effective in decreasing tremor amplitude in ET;
2. this effect is strongest when the delivery of tACS is locked to the phase of the tremor
expressed by the patient, i.e. administering tACS in a closed-loop modality;
3. transcutaneous ACS in the upper extremities is as effective as tACS applied to the scalp
around M1.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | August 2022 |
Est. primary completion date | October 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Participants who meet Diagnostic and Statistical Manual of Mental Disorders criteria for ET (APA, DSM V). - 18 years of age or older. - Participants should be either un-medicated or on stable medication treatment for tremor for the previous 3 months. - Psychiatric comorbidities should be clinically stable; treatment has not changed in the last 3 months. Exclusion Criteria: - Have a metal object/implant in their brain, skull, scalp, or neck. - Have an implantable device (e.g., cardiac pacemaker). - Have a diagnosis of epilepsy or cardiac disease. - Have a history of traumatic brain injury, learning disability or dyslexia. - Have a severe impediment in vision or hearing. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Essential Tremor Severity Change | The tremor severity will be assessed in the participants by a Movement Disorders Neurologist. | Right before and immediately after the intervention |
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