Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome
- Conditions
- Mal de Debarquement Syndrome
- Interventions
- Device: Transcranial Magnetic Stimulation
- Registration Number
- NCT02470377
- Lead Sponsor
- University of Minnesota
- Brief Summary
The goal of this study is to determine whether external neuromodulation using repetitive transcranial magnetic stimulation (rTMS) can reduce the perception of self-motion that is experienced by individuals with mal de debarquement syndrome (MdDS). Mal de debarquement is translated as the "sickness of disembarkment," and refers to the chronic feeling of rocking dizziness that occurs after exposure to passive motion. Treatment for MdDS is limited and morbidity is high. The goal of the study is to determine whether rTMS can suppress the rocking dizziness of MdDS.
- Detailed Description
Participants will maintain web-based diaries of their symptoms for two weeks prior to treatment with rTMS. Up to 20 treatments with rTMS with either anatomically or functionally determined targets will be administered. Post treatment diaries will continue for up to 12 weeks after rTMS administration.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Target 1: Occipital Cortex Transcranial Magnetic Stimulation After determination of the motor threshold, the TMS coil will be positioned over the midline occipital cortex using MRI guidance and a frameless stereotaxy system. A train of stimulation pulses in continuous theta burst mode will be delivered. Target 2: Cerebellar Vermis Transcranial Magnetic Stimulation After determination of the motor threshold, the TMS coil will be positioned over the midline cerebellar vermis using MRI guidance and a frameless stereotaxy system. A train of stimulation pulses in continuous theta burst mode will be delivered. Target 3: Cerebellar Hemisphere Transcranial Magnetic Stimulation After determination of the motor threshold, the TMS coil will be positioned over the lateral cerebellar hemisphere using MRI guidance and a frameless stereotaxy system. A train of stimulation pulses in continuous theta burst mode will be delivered.
- Primary Outcome Measures
Name Time Method Dizziness Handicap Inventory 10 weeks (4 pre stimulation + 6 post stimulation) The Dizziness Handicap Inventory is a widely used measure of subjective dizziness in which 25 questions of dizziness inducing events are rated on a scale of 0-2-4. The maximum number of points is 100 points which are divided into the following levels: 16-34 Points (mild handicap), 36-52 Points (moderate handicap), 54+ Points (severe handicap).
- Secondary Outcome Measures
Name Time Method Mal de Debarquement Balance Rating Scale 10 weeks (4 pre stimulation + 6 post stimulation) The MdDS Balance Rating Scale is a 10-point scale inquiring about the severity of rocking vertigo in which 1 means no rocking and 10 is so severe that standing is not possible. A level of 6 indicates that gait is impaired due to the severity of rocking.
Hospital Anxiety and Depression Scale 10 weeks (4 pre stimulation + 6 post stimulation) The Hospital Anxiety and Depression Scale is a widely used scale that inquires about anxiety and depression symptoms with 14 questions divided into 7 questions about anxiety and 7 questions about depression. Each item is rated from 0-3 per item yielding a maximum of 21 points per item. Each subscale is rated as follows: 0-7 (Normal), 8-10 (Borderline), 11-21 (Abnormal).
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States