Alternating Current Stimulation for Essential Tremor

NCT04509349 | Unknown

• 1 other identifier: REB20-0889
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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 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. 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. 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. 3.transcutaneous ACS in the upper extremities is as effective as tACS applied to the scalp around M1.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Device: transcranial Altering Current Stimulation; Device: Sham tACS

Interventions

transcranial Altering Current Stimulation DEVICE

The participant will wear an electrode cap with 5 gel-filled cup HD electrodes arranged in a 4 x 1 montage.

Real tACS; Sham tACS

Sham tACS DEVICE

2 saline sponge electrodes will be attached to the upper arm contralateral to hand attached to the accelerometer.

Real tACS; Sham tACS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who meet Diagnostic and Statistical Manual of Mental Disorders criteria for ET (APA, DSM V).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Davide Martino, MD, PhD

  Department of Clinical Neurosciences, University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaheh NosratMirshekarlou, MSc

CONTACT

0014032106876; elaheh.nosratmirshek@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: August 12, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: August 1, 2022
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share