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CRPS - Diagnostics, Pathophysiological Mechanisms, and Response to Treatment With Noninvasive Brain Stimulation

NCT04439669 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-07-03

No results posted yet for this study

Summary

This is a sham controlled, randomized, double-blind, navigated repetitive Transcranial Magnetic Stimulation (nrTMS) study for the treatment of complex regional pain syndrome (CRPS types 1 and 2). The investigators study factors that may contribute to development, maintenance, or treatment responses with clinical, sleep, and psychiatric questionnaires and clinical examinations, quantitative sensory testing and neurophysiologic recordings, genetics, and MRI techniques.

Conditions

  • Transcranial Magnetic Stimulation
  • Complex Regional Pain Syndrome of Upper Limb (Disorder)

Interventions

DEVICE

Sham nrTMS and open phase

Navigated repetitive TMS treatment (10 sessions during a three-week period) randomized to sham. In the following open phase stimulation the treatment targets are the right "S2"-contralateral M1-left "S2".

DEVICE

Active nrTMS and open phase

Navigated repetitive TMS treatment (10 sessions during a three-week period) randomized to "S2". In the following open phase stimulation the treatment targets are contralateral M1 and left "S2". If the patient benefited from active "S2" stimulation, but the treatment effect faded in follow-up, the open phase stimulation starts with right "S2".

Sponsors & Collaborators

  • Turku University Hospital

    collaborator OTHER_GOV

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Eija Kalso, Professor · Helsinki University Hospital, Pain Clinic

  • Satu Jääskeläinen, Professor · Turku University Hospital, Dept. of Clinical Neurophysiology

  • Hanna Harno, MD, PhD · Helsinki University Hospital, Pain Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2021-07-29
Completion
2022-08-25

Countries

  • Finland

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 NCT04439669 on ClinicalTrials.gov