Focused ultrasound pallidothalamic tractotomy for cervical dystonia

JRCT ID: jRCTs032210506

Registered date:22/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cervical dystonia
• Date of first enrollment: 10/03/2022
• Target sample size: 10
• Study type: Interventional

Intervention(s)

MR-guided focused ultrasound pallidothalamic tractotomy:
hair-shaved, frame fixation, MRI/CT, on the MRI/Exablate Transcranial MRgFUS therapy table, treatment sonication with intraoperative MR thermometry
the procedure takes 60-180 minutes
postoperative MRI confirm the lesion location and complications

Outcome(s)

• Primary Outcome: 6-month postoperative Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
• Secondary Outcome: BFMDRS, BDI, BAI, AES, MMSE, Postoperative neurological deficit

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

1) cervical dystonia
2) Age: 20-70
3) Toronto Western SpasmodicTorticollis Rating Scale severity scale more than 15
4) medically and botulinum toxin injection refractory cervical dystonia
5) patient who can understand the study protocol by oneself

Exclude criteria

1) inability to stop antiplatelete or anticoagulant medications
2) inability to take MRI
3) lactating or pregnant woman
4) on hemodialysis
5) intractable hypertension ( diastolic pressure > 100)
6) past history of cranial surgery
7) past history of cervical surgery
8) past history of stroke
9) past history of structural lesion in the brain
10) progressive neurodegenerative disease
11) past history of psychiatric disorders
12) Any patient that in the investigator's opinion preclude participation in this study.

Related Information

• Primary Sponsor: Shiro Horisawa
• Source(s) of Monetary Support: The Focused Ultrasound Foundation