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Evaluation of Non-invasive Peripheral Nerve Stimulation in Action Tremor (Device Clinical Test)

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)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20161212031362N2
Enrollment
84
Registered
2022-09-12
Start date
2022-09-22
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Action Tremor. Essential tremor

Interventions

Intervention 1: Intervention group: Electrical stimulation of two median and radial nerves with a frequency of 150 Hz, by a wristband device. Intervention 2: Control group: Sham-stimulation of two me

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with Action Tremor

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.;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.;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.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hossein Harirchian

Tehran University of Medical Sciences

harirchm@tums.ac.ir+98 21 6694 8899

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026