---
title: Neurostimulation Device for Treatment of Migraine Headache
nct_id: NCT01630044
overall_status: COMPLETED
phase: NA
sponsor: Scion NeuroStim
study_type: INTERVENTIONAL
primary_condition: Migraine Headache
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01630044.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01630044"
ct_last_update_post_date: 2025-03-30
last_seen_at: "2026-05-12T06:35:03.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Neurostimulation Device for Treatment of Migraine Headache

**Official Title:** Clinical Pilot Study to Evaluate a Non-Invasive, Neurostimulation Device for Treatment of Migraine Headache

**NCT ID:** [NCT01630044](https://clinicaltrials.gov/study/NCT01630044)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 3
- **Lead Sponsor:** Scion NeuroStim
- **Conditions:** Migraine Headache
- **Start Date:** 2012-05
- **Completion Date:** 2013-04
- **CT.gov Last Update:** 2025-03-30

## Brief Summary

This is a single-site, prospective, non-randomized and open label study to investigate the feasibility of home-use CVS for the prevention of episodic migraine headache and specifically to better understand what type of waveform to apply.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* A history of at least four, and not more than fourteen total monthly headache days of which between four and nine were migraine headache days. (Note: Patients were permitted continued access to migraine abortive medications and were being treated at the Duke University headache clinic.)
* A history of some responsiveness (incomplete) to at least one and a maximum of two prophylactic pharmaceutical therapies (utilized concurrently);
* The investigator must have confidence in the patient's ability to reliably complete and return the Daily Headache Diary.
* Subject must be at least 18 years of age.

Exclusion Criteria:

* Individuals who were pregnant, who had a history of cardiovascular disease, who worked night shifts or who had vestibular migraine, menstrual migraine, post-traumatic migraine, a history of unstable mood disorder or unstable anxiety, moderate or greater hearing loss or a history of traumatic brain injury.
* A history within the last six months of tobacco use, narcotic or barbiturates use or experiencing one or more analgesic rebound headaches.
```

## Arms

- **TNM device, active treatment** (EXPERIMENTAL) — This is an active-only assessment of the experimental neuromodulation device

## Interventions

- **TNM device** (DEVICE) — Non-invasive neurostimulator, home-use treatment for up to 43 days.

## Primary Outcomes

- **Number of migraine headache days** _(time frame: Length of the study, about 71 days)_ — Daily Headache Diary will be used by subject. A headache day is defined as a twenty-four hour period which the subject has a headache.
- **Severity of each and of all headaches** _(time frame: Length of study, 71 days)_ — Daily Headache Diary will be used by subject. Subject will assign the level of pain based on an eleven-point pain measurement scale from zero (no pain) to ten (most intense pain).

## Secondary Outcomes

- **Total Monthly Headache Pain Score** _(time frame: Length of study, about 71 days)_

## Locations (1)

- Duke Medicine / Neurology, Durham, North Carolina, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.duke medicine / neurology|durham|north carolina|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01630044.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01630044*  
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