Effects of High Amplitude and Focused tACS on Entraining Physiological Tremor

Tremor, Limb Clinical Trial

Official title:

Effects of High Amplitude and Focused tACS on Entraining Physiological Tremor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337334
• Other study ID #: S57869
• Status: Completed
• Phase: N/A
• First received: November 1, 2017
• Last updated: November 8, 2017
• Start date: June 2016
• Est. completion date: April 2017

Study information

• Verified date: November 2017
• Source: Katholieke Universiteit 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. While tACS applied over the motor cortex at the general applied amplitude (1 mA) and using patch electrodes has been shown to entrain physiological tremor in healthy volunteers, the aim of this study is to test the feasibility of using high-amplitude tACS and to assess the effect of different electrode montages and stimulation sites in entraining physiological tremor. First, 10 subjects (arm 1) will be stimulated with 2 mA current amplitude applied between saline soaked patch square electrodes and comparison will be done between motor cortex stimulation and peripheral cortex stimulation. Then, 10 subjects (arm 2) will be stimulated using focused 4x1 montage with gel-filled cup-electrodes and 5 mA amplitude and comparison will be made between motor cortex and occipital cortex stimulation. Three outcome measurements will be measured during the experiments which are: tremor entrainment, phosphene intensity and phosphene threshold.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Above 18

• signed informed written consent

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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tremor-stimulation phase entrainment	phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal	During the 36 minutes of all sessions (3 sessions each of is 12 minutes)
Secondary	Phosphene rating	The subject is asked to rate the phosphene intensity during the stimulation using a visual analog scale from 0 to 10. Zero means no phosphene is perceived and the number starts to increase as the phosphene perception intensity increases to reach 10 if the subject observe only a white view	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	Phosphene threshold	Stimulation amplitude at which the subject starts to perceive phosphene. Stimulation starts with 0 mA amplitude and then increased gradually until phosphene 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 sec.