Essential TremorNCT04509349
Alternating Current Stimulation for Essential Tremor
A study testing transcranial Altering Current Stimulation in people with Essential Tremor, run by University of Calgary.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- transcranial Altering Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Essential Tremor
- Being tested
- transcranial Altering Current Stimulation, Sham tACS
- 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 Altering Current StimulationDevice
The participant will wear an electrode cap with 5 gel-filled cup HD electrodes arranged in a 4 x 1 montage.
Sham tACSDevice
2 saline sponge electrodes will be attached to the upper arm contralateral to hand attached to the accelerometer.
| Study group | Role | What they receive |
|---|---|---|
| Real tACS | Active comparator | 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. Receives: Device: transcranial Altering Current Stimulation; Device: Sham tACS |
| Sham tACS | Placebo comparator | 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. Receives: Device: transcranial Altering Current Stimulation; Device: Sham tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Essential Tremor Severity Change
The tremor severity will be assessed in the participants by a Movement Disorders Neurologist.
Measured: Right before and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionAug 2022 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davide Martino, MD, PhD, Principal investigator, Department of Clinical Neurosciences, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509349
- Sponsor's protocol ID
- REB20-0889
- Status last verified
- Aug 2020
- First submitted
- 20 Jul 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternating Current Stimulation for Essential Tremor: a Pilot Study to Identify the Most Promising Strategy
- ClinicalTrials.gov ID
- NCT04509349
- Acronym / sponsor ID
- REB20-0889
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 12 Aug 2020 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real tACS | Active comparator | Device: transcranial Altering Current Stimulation, Device: Sham tACSFor 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. |
| Sham tACS | Placebo comparator | Device: transcranial Altering Current Stimulation, Device: Sham tACSFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 Altering Current StimulationThe participant will wear an electrode cap with 5 gel-filled cup HD electrodes arranged in a 4 x 1 montage. | Device | Real tACS, Sham tACS |
| Sham tACS2 saline sponge electrodes will be attached to the upper arm contralateral to hand attached to the accelerometer. | Device | Real tACS, Sham tACS |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Essential Tremor
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Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
RecruitingObservational study
Phenotype/Genotype Correlations in Movement Disorders
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RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
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Coordinated Reset Deep Brain Stimulation for Essential Tremor
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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.
Davide Martino, MD, PhD principal investigator
Department of Clinical Neurosciences, University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Altering Current Stimulation in people with Essential Tremor, run by University of Calgary.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Sep 2020. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elaheh NosratMirshekarlou, MSc (0014032106876, elaheh.nosratmirshek@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Essential Tremor Severity Change (time frame: Right before and immediately after the 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 2 Sep 2020.