- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04509349
Alternating Current Stimulation for Essential Tremor
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:
- focused (or high definition, HD) tACS delivered over M1 at the same frequency of the tremor is effective in decreasing tremor amplitude in ET;
- 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;
- transcutaneous ACS in the upper extremities is as effective as tACS applied to the scalp around M1.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This investigation will collect preliminary data on the efficacy of real vs. sham, as well as unlocked vs. phase-locked, modalities of tACS and transcutaneous ACS on tremor amplitude in 25 patients with ET.
Comparing transcranial and transcutaneous, as well as unlocked and phase-locked, modalities represents the novelty of our approach. This has the potential to generate a wealth of preliminary data forming the basis of a large, randomized controlled trial of multiple sessions of this intervention, hence potentially capable of producing long-lasting effects, in this common and disabling disorder. Given its non-invasiveness and relatively low cost, this approach has, if effective, a huge therapeutic potential in ET.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Real tACS
For transcranial stimulation, a stimulation method called high-definition tACS (HD-tACS) will be applied to target the primary motor cortex (M1), an area of the brain that is involved in controlling movement, using gel electrodes placed on the scalp.
Participant will wear an electrode cap with 5 gel-filled cup HD electrodes arranged in a 4 x 1 montage, to create focused stimulation over the M1 region.
A stimulator will be connected to the electrodes to deliver a low-intensity stimulating current to the scalp.
|
The participant will wear an electrode cap with 5 gel-filled cup HD electrodes arranged in a 4 x 1 montage.
2 saline sponge electrodes will be attached to the upper arm contralateral to hand attached to the accelerometer.
|
Placebo Comparator: Sham tACS
For the transcutaneous ACS, the procedure for real and sham stimulation will be identical to HD-tDCS, but ACS will be delivered to the upper arm contralateral to hand attached to the accelerometer.
|
The participant will wear an electrode cap with 5 gel-filled cup HD electrodes arranged in a 4 x 1 montage.
2 saline sponge electrodes will be attached to the upper arm contralateral to hand attached to the accelerometer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Essential Tremor Severity Change
Time Frame: Right before and immediately after the intervention
|
The tremor severity will be assessed in the participants by a Movement Disorders Neurologist.
|
Right before and immediately after the intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB20-0889
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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