Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04509349
Status:
UNKNOWN
Last Update Posted:
2020-09-02
First Post:
2020-07-20
Brief Title:
Alternating Current Stimulation for Essential Tremor
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Alternating Current Stimulation for Essential Tremor a Pilot Study to Identify the Most Promising Strategy
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 body site ET occurs in between 04 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 Parkinsons 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 skins peripheral nerves transcutaneous ACS but its effect on tremor amplitude is unknown
METHODS AND POTENTIAL CONTRIBUTIONIMPACT 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 ie 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
METHODS AND POTENTIAL CONTRIBUTIONIMPACT 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 ie 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None