IRCT | Evaluation of Non-invasive Median and Radial Nerve Stimulation in tremor alleviating in Patients with Action Tremor: A double-arm, randomized, double-blind clinical trial (Device Clinical Test)

Protocol summary

Study aim: Investigating the effect of peripheral stimulation of median and radial nerves on amplitude and frequency of active tremor of the hand after 40 minutes of electrical stimulation
Design: A two-arm, double-blind, sham-controlled clinical trial with an 84-samplesize, Block randomized by https://www.sealedenvelope.com/simple-randomiser/v1/lists, website.
Settings and conduct: The patient receives electrical or artificial stimulation by a wristband device; Study participants, outcome assessors, and data analysts are blinded. Neurology clinic, Iranian Center of Neurological Research, Imam Khomeini Hospital, Tehran University of Medical Sciences.
Participants/Inclusion and exclusion criteria: Participants: patients with active hand tremor / Inclusion Criteria: over 18 years old, confirmation of active tremors by a neurologist, if taking medication for tremor dose and type of medication from one month before the start of this study and during the study. Exclusion Criteria: advanced liver and kidney disease, patient with medical electrical equipment in the body such as: pacemaker, defibrillator, deep brain stimulation, history of thalamotomy, epilepsy disorders, peripheral neuropathy, severe dependence on alcohol or caffeine, platinum in the forearm , pregnancy, use of botulinum treatment for hand tremor in the past six months, other neurodegenerative diseases, change of medication or addition of a new medication from one month before or during the study
Intervention groups: Intervention group: Electrical stimulation by a wristband device of two median and radial nerves with a frequency of 150 Hz Control group: Sham-stimulation with a frequency of 7 Hz by wristband device
Main outcome variables: The Essential Tremor Rating Assessment (TETRAS); BF-activities of daily living (BF-ADL) ; Clinical global impressions (CGI-I); Tremor power

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20161212031362N2

Registration date: 2022-09-12, 1401/06/21

Registration timing: prospective

Last update: 2022-09-12, 1401/06/21

Update count: 0
Registration date: 2022-09-12, 1401/06/21

Registrant information: Name

Mohammad Hossein Harirchian

Name of organization / entity

Iranian center of neurological research

Country

Iran (Islamic Republic of)

Phone

+98 21 6694 8899

Email address

harirchm@tums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2022-09-22, 1401/06/31
Expected recruitment end date: 2023-05-21, 1402/02/31
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Evaluation of Non-invasive Median and Radial Nerve Stimulation in tremor alleviating in Patients with Action Tremor: A double-arm, randomized, double-blind clinical trial (Device Clinical Test)

Public title: Evaluation of Non-invasive Peripheral Nerve Stimulation in Action Tremor (Device Clinical Test)
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Patients with Action Tremor

Exclusion criteria:

Advanced liver disease Advanced renal disease Patients with Implemented electrical medical device such as: pacemaker, defibrillator, Deep brain stimulation A history of thalotomy Epileptic disorders Peripheral neuropathy Severe addiction to alcohol or caffeine Platinum in forearm Skin sores at the site of stimulation Pregnancy Receive botulinum treatment for hand tremors during the past six months Any neurodegenerative diseases Changing the medication or adding a new medication one month before
Age: From 18 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Outcome assessor
Data analyser

Sample size

Target sample size: 84

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization method: Block (ُSample Size: 84 (21 Blocks) Randomization Unit: Individual Random sequence by Rand Excel; Website: https://www.sealedenvelope.com/simple-randomiser/v1/lists

Blinding (investigator's opinion)

Double blinded

Blinding description

The wristband device is designed with the ability to adjust the electrical stimulation and artificial stimulation, which are named A and B by the researcher. Study participants, outcome assessors, and data analysts are blinded.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethic Committee of Neuroscience Institute , Tehran University of Medical Sciences

Street address

Neuroscience Institute, Imam Khomeini Hospital complex; Keshavarz Blvd

City

Tehran

Province

Tehran

Postal code

۱۴۱۹۷۳۳۱۴۱
Approval date: 2022-08-04, 1401/05/13
Ethics committee reference number: IR.TUMS.NI.REC.1401.039

Health conditions studied

1

Description of health condition studied: Patients with Action Tremor
ICD-10 code: G25.0
ICD-10 code description: Essential tremor

Primary outcomes

1

Description: The Essential Tremor Rating Assessment (TETRAS) scale- 6 task Archimedes score
Timepoint: Before electrical stimulation, 15 minutes after stimulation, then at intervals of 30 minutes, 60 minutes, 90 minutes, 120 minutes after electrical stimulation.
Method of measurement: The Essential Tremor Rating Assessment (TETRAS) and score calculation

2

Description: Bain and Findley activities of daily living (BF-ADL) test score
Timepoint: Before electrical stimulation, 15 minutes after stimulation, then at intervals of 30 minutes, 60 minutes, 90 minutes, 120 minutes after electrical stimulation.
Method of measurement: Bain and Findley activities of daily living (BF-ADL) questionnaire and score calculation

3

Description: Patient's report of improvement by Clinical global impressions (CGI-I) questionnaire
Timepoint: Before electrical stimulation, 15 minutes after stimulation, then at intervals of 30 minutes, 60 minutes, 90 minutes, 120 minutes after electrical stimulation.
Method of measurement: Clinical global impressions questionnaire and score calculation

4

Description: Tremor power (Frequency)
Timepoint: Before electrical stimulation, 15 minutes after stimulation, then at intervals of 30 minutes, 60 minutes, 90 minutes, 120 minutes after electrical stimulation.
Method of measurement: ٍElectrical Stimulation Wristband device

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: Electrical stimulation of two median and radial nerves with a frequency of 150 Hz, by a wristband device
Category: Treatment - Devices

2

Description: Control group: Sham-stimulation of two median and radial nerves with a frequency of 7 Hz, for 15 seconds by a wristband device
Category: Treatment - Devices

Recruitment centers

1

Recruitment center: Name of recruitment center

Iranian Center of Neurological Research

Full name of responsible person

Mohammad Hossein Harirchian

Street address

Iranian Center of Neurological Research, Imam Khomeini Hospital Complex, Keshavarz Blvd

City

Tehran

Province

Tehran

Postal code

1419733141

Phone

+98 21 6694 8899

Email

harirchm@tums.ac.ir

Web page address

https://isid.research.ac.ir/MohammadHosein_Harirchian

1

Sponsor: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Dr Ali Akbar Fotouhi

Street address

Keshavarz Blvd, Qods Town.

City

Tehran

Province

Tehran

Postal code

۱۴۱۷۶۵۳۷۶۱

Phone

+98 21 81631

Email

tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Tehran University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Mohammad Hossein Harirchian

Position

Professor of Neurology

Latest degree

Specialist

Other areas of specialty/work

Neurology

Street address

Iranian Center of Neurological Research, Imam Khomeini Hospital, Keshavarz Boulevard

City

Tehran

Province

Tehran

Postal code

1419733141

Phone

+98 21 6694 8899

Fax

+98 21 6658 1558

Email

harirchm@tums.ac.ir

Web page address

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Mohammad Hossein Harirchian

Position

Professor of Neurology

Latest degree

Specialist

Other areas of specialty/work

Neurology

Street address

Fourth Floor, Iranian Center of Neurological Research Building, Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran.

City

Tehran

Province

Tehran

Postal code

1419733141

Phone

+98 21 6694 8899

Fax

+98 21 6658 1558

Email

harirchm@tums.ac.ir

Web page address

Person responsible for updating data

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Mohammad Hossein Harirchian

Position

Professor of Neurology

Latest degree

Specialist

Other areas of specialty/work

Neurology

Street address

Fourth Floor, Iranian Center of Neurological Research Building, Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran.

City

Tehran

Province

Tehran

Postal code

1419733141

Phone

+98 21 6694 8899

Fax

+98 21 6658 1558

Email

harirchm@tums.ac.ir

Web page address

https://isid.research.ac.ir/MohammadHosein_Harirchian

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

Evaluation of Non-invasive Median and Radial Nerve Stimulation in tremor alleviating in Patients with Action Tremor: A double-arm, randomized, double-blind clinical trial (Device Clinical Test)