The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS

Tremor, Limb Clinical Trial

Official title:

The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065022
• Other study ID #: S57869-1
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: January 16, 2018

Study information

• Verified date: August 2019
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transcranial alternating current stimulation (tACS) is a noninvasive neuromodulation method that works by passing alternating electric current between electrodes where at least one of them is attached to the head. This has been shown to have effects on the motor system, cognition and behavior. The exact mechanism by which tACS causes such effects is not fully understood. Some studies suggests a contribution from the stimulated peripheral nerves present in the scalp rather than direct brain effects. To test this hypothesis two arms will be done. First, 12 subjects (arm 1) will be stimulated using focused 4x1 montage with gel-filled cup-electrodes over the motor cortex and the effects will be compared between anesthetized and non-anesthetized scalp. The effects of anesthetizing the scalp will be tested on three different stimulation amplitudes off (0 mA), low (0.5 mA) and high (2.5 mA). Then, 10 subjects (arm 2) will be stimulated over the contralateral arm to exclude any direct brain stimulation effects and to test if peripheral nerve stimulation can entrain the tremor. Three outcome measurements will be measured during the experiments which are: tremor entrainment, sensation intensity and sensation threshold.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 16, 2018
• Est. primary completion date: January 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Above 18

• Signed informed consents

Exclusion Criteria:

• Pregnancy

• History of Epilepsy

• Family history of Epilepsy

Related Conditions & MeSH terms

• Essential Tremor
• Tremor
• Tremor, Limb

Intervention

Device:
• tACS at tremor frequency
tACS applied between the stimulation electrodes at tremor frequency

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tremor-stimulation phase entrainment- Session 1	phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal	During session one of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
Primary	Change in tremor-stimulation phase entrainment- Session 2	phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal	During session two of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
Primary	Change in tremor-stimulation phase entrainment- Session 3	phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal	During session three of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
Secondary	Sensation rating	The subject is asked to rate the sensation intensity during the stimulation at each stimulation amplitude using a visual analog scale from 0 to 10. Zero means the subject doesn't feel the stimulation and the number starts to increase as the sensation perception intensity increases to reach 10 if the subject feels it painful.	Measured up to 5 minutes before the start of the stimulation sessions and lasts for 10 seconds of stimulation after which the subject gives the rating
Secondary	Sensation threshold	Stimulation amplitude at which the subject starts to feel the stimulation. Stimulation starts with 0 mA amplitude and then increased gradually until stimulation is perceived (or reaching maximum amplitude).	Measured 3 minutes before the start of the stimulation sessions and lasts up to 2 minutes. Stimulation at each amplitude lasts for 10 seconds