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GAIN Symptoms: Post-traumatic Headache

NCT05857761 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-05-01

No results posted yet for this study

Summary

The overall aim of the study is to advance the knowledge on the characterization and underlying pathophysiological mechanisms of persistent post-traumatic headache (PTH) with a direct impact on the ability to diagnose and manage PTH effectively. The investigators also aim to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS), a novel intervention on PTH.

Conditions

  • Post-Traumatic Headache
  • Concussion, Mild
  • MTBI - Mild Traumatic Brain Injury

Interventions

DEVICE

Active repetitive transcranial magnetic stimulation (rTMS)

Five sessions of active rTMS therapy will be distributed over 2 weeks (20 Hz, 2000 pulses, 90% resting motor threshold) will be delivered to left dorsolateral pre-frontal cortex (DLPFC) around 6 months post-trauma.

DEVICE

Sham repetitive transcranial magnetic stimulation (rTMS)

Five sessions of sham rTMS therapy will be distributed over 2 weeks

Sponsors & Collaborators

  • Hammel Neurorehabilitation Centre and University Research Clinic

    collaborator OTHER

  • Central Denmark Region

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Jørgen Feldbæk Nielsen, Proffessor · Research Unit Hammel Neurocenter

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-28
Primary Completion
2024-08-31
Completion
2027-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05857761 on ClinicalTrials.gov