Gamma Knife Radiosurgery for Treatment of Essential Tremor

NCT02255929 | Unknown FDA Device

• 1 other identifier: IR 5585
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine effects (good and bad) of gamma knife radiosurgery for essential tremor. The gamma knife places a small lesion in the brain to suppress tremors.

Conditions

Essential Tremor

Keywords

Benign Essential Tremor; Tremor; Neurologic Manifestations; Nervous System Diseases; Movement Disorders; Central Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

• Change in Effectiveness based on Clinical Rating Scale for Tumor (CRST-Part B) questionnaires.

  The change observed is represented by a writing and drawing score assessment of tremors. The assessment is conducted by a movement disorder neurologist in a blinded fashion.

  Baseline, 6, 12, 24, and 36 Months Post Treatment

Secondary Outcomes (1)

• Safety Based on the Number of Incidences and Severity of Adverse Events Related with Gamma Knife Thalamotomy

  Baseline, 6, 12, 24, and 36 Months Post Treatment

Study Arms (1)

Gamma Knife Radiosurgery

EXPERIMENTAL

Gamma Knife treatment is conducted in one day and takes approximately 70 to 90 minutes.

Radiation: Gamma Knife Radiosurgery

Interventions

Gamma Knife Radiosurgery RADIATION

Gamma Knife Radiosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age 18 years or older
• Diagnosis of essential tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon
• Tremor following prior first line therapy with either propranolol or primidone
• Must be able to undergo MRI of brain and CT of head for treatment planning
• Postural or intention tremor severity score of greater than or equal to 2 in one hand/arm as measured by the CRST rating scale

You may not qualify if:

• Prior ipsilateral stereotactic radiosurgical ablation of the thalamus, ipsilateral deep brain stimulation, radiofrequency ablation of a ipsilateral thalamic target, or ultrasound ablation of an ipsilateral thalamic target
• Prior whole brain radiation therapy
• Pregnancy

Sponsors & Collaborators

• Swedish Medical Center: lead

Study Sites (1)

Swedish Medical Center Radiosurgery Center

Seattle, Washington, 98122, United States

Location

Related Links

• Click here for more information about the Swedish Medical Center Radiosurgery Center

MeSH Terms

Conditions

Essential Tremor; Tremor; Neurologic Manifestations; Nervous System Diseases; Movement Disorders; Central Nervous System Diseases

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Dyskinesias; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christopher Loiselle, MD

  Swedish Medical Center Radiosurgery Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: October 3, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

US (1)