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NCT00954421 · ClinicalTrials.gov registry record · NA

Use of Two Deep Brain Stimulation (DBS) Electrodes to Treat Post-Traumatic Tremor

A NA study, sponsored by University of Florida.

Completed
Registry status
NA
Development phase
16
Enrollment target

NCT00954421: Completed NA study, sponsored by University of Florida.

NCT00954421 is a NA study that has completed, run by University of Florida. The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00954421, a NA study, has completed, sponsored by University of Florida.

COMPLETED
Registry status
NA
Development phase
16 participants
Enrollment target

Study Summary

The purpose of this research study is to: 1. Determine whether deep brain stimulation (DBS) with two leads (very thin coiled wires) placed unilaterally (on one side of the brain) is beneficial to patients with multiple sclerosis (MS) tremor. 2. Compare the two different locations of the DBS lead placement in effectiveness for treatment of muscle tremors that do not respond to treatment with medication caused by multiple sclerosis. 3. Evaluate any side effects that may result from the two DBS leads.

Primary Outcome

Tremor was evaluated using the Fain-Tolosa-Marin Tremor Rating Scale (TRS). Score was obtained by summing all 21 items, each of which assessed tremor on a scale of 0-4. Because some of the 21 items contained more than one subsection, total maximum score was 144, and minimum score was 0. Higher scores represent worse tremor. Both VIM and VO stimulators will be turned ON and TRS score at 6 months will be compared to pre-implant (baseline).

Interventions

  • DEVICE Deep Brain Stimulation

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2006-11
Est. Completion 2013-12
Phase NA
University of Florida

1,106 total trials

What the finished NCT00954421 record still lists

NCT00954421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Deep Brain Stimulation is the first listed.

NCT00954421 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00954421 about?

NCT00954421 is a clinical study titled "Use of Two Deep Brain Stimulation (DBS) Electrodes to Treat Post-Traumatic Tremor". The purpose of this research study is to: 1. Determine whether deep brain stimulation (DBS) with two leads (very thin coiled wires) placed unilaterally (on one side of the brain) is beneficial to patients with multiple sclerosis (MS) tremor. 2. Compare the two different locations of the DBS lead pl...

What is the current status of trial NCT00954421?

This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2006-11. Estimated completion is 2013-12.

What interventions are being tested in trial NCT00954421?

The interventions under investigation include: Deep Brain Stimulation (DEVICE).

Who is sponsoring clinical trial NCT00954421?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00954421's enrollment target sits among peer trials

16 1871st of 2000 higher than 120 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00954421, the US trial registry maintained by the National Library of Medicine. NCT00954421 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.