Transcranial Magnetic Stimulation in Spino-Cerebellar Ataxia
TMS
2 other identifiers
interventional
20
1 country
1
Brief Summary
Spinocerebellar Ataxia (SCA) refers to a family of genetic diseases that cause progressive problems with gait and balance, as well as other debilitating symptoms. This is a randomized controlled pilot study to test a novel therapeutic intervention that uses noninvasive magnetic brain stimulation to improve functional outcomes in patients with SCA. The study will include quantitative evaluations of gait, balance, and brain physiology to examine possible objective end-points for a future, larger multi-site clinical trial. The investigators anticipate that patients receiving the real intervention will show a functional gain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 24, 2013
CompletedFirst Posted
Study publicly available on registry
November 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
May 30, 2017
CompletedMay 30, 2017
April 1, 2017
3.1 years
September 24, 2013
March 2, 2017
April 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA)
Assess 8 items: gait, stance, sitting, speech, dysmetria, kinetic tremor, pro- and supinations of the hand, and the heel-shin slide. Each item is scored by the physician on a 4 to 8 numerical scale based upon the amount of dysfunction observed while performing the task. The maximum possible score for the total scale is 40. Lower scores of SARA represents better task performance.
Baseline and 1 week post treatment
Secondary Outcomes (2)
Percent Change From Baseline to Post Treatment on the Timed 25-Foot Walk
Baseline and 1 week post treatment
Percent Change From Baseline to Post Treatment on the 9-hole Peg Test
Baseline and 1 week post treatment
Other Outcomes (3)
Percent Change From Baseline to Post Treatment on Gait Speed in 90 Second Walking Test
Baseline and 1 week post treatment
Percent Change From Baseline to Post Treatment on Standing Postural Control
Baseline and 1 week post treatment
Percent Change From Baseline to Post Treatment on Mobility and Turning
Baseline and 1 week post treatment
Study Arms (2)
Transcranial Magnetic Stimulation (TMS)
ACTIVE COMPARATORA Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.
Sham Transcranial Magnetic Stimulation
SHAM COMPARATORA sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.
Interventions
0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.
Eligibility Criteria
You may qualify if:
- Outpatients with ataxia as diagnosed by a movement disorder specialist and confirmed by clinically obtained genetic testing of the patient and/or in a first-degree relative of the patient.
- Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study
- Stable on doses of all medications for at least 30 days prior to study entry and for the duration of the study
- The ability to ambulate
- A score of three or higher (worse) on the 'gait' subsection of the Scale of the Assessment and Rating of Ataxia (SARA) rating scale.
You may not qualify if:
- Any unstable illness or concomitant medical condition that, in the investigator's opinion, precludes participation in this study, including disorders that may affect gait or balance (i.e., stroke, arthritis, etc).
- The presence of clinically significant abnormalities on screening CBC, CMP or EKG.
- Pregnancy or lactation
- Concurrent participation in another clinical study
- A history of substance abuse
- The presence of psychosis, bipolar disorder, untreated depression (BDI greater than or equal to 21), or history of suicide attempt.
- Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
- Legal incapacity or limited legal capacity.
- Ataxia derived from any cause other than genetically-confirmed SCA (including but not limited to alcoholism, head injury, Multiple Sclerosis, olivo-ponto-cerebellar atrophy or multiple system atrophy).
- The patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other CNS active drugs.
- The published TMS guidelines review of medications to be considered with TMS.
- History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG.
- Known metal in the head (such as a surgical aneurysm clip) or a history of prior neurosurgical procedures.
- Ferromagnetic bioimplants activated by any electronic, mechanical or magnetic means, such as cochlear implants, pacemakers, medication pumps, vagal stimulators, deep brain stimulators, neurostimulators, biostimulators, or ventriculo-peritoneal shunts.
- Subjects who have or might have bullet fragments or other shrapnel (veterans or workers exposed to metal in their work environment).
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
Manor B, Greenstein PE, Davila-Perez P, Wakefield S, Zhou J, Pascual-Leone A. Repetitive Transcranial Magnetic Stimulation in Spinocerebellar Ataxia: A Pilot Randomized Controlled Trial. Front Neurol. 2019 Feb 12;10:73. doi: 10.3389/fneur.2019.00073. eCollection 2019.
PMID: 30809184DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brad Manor, Ph.D.
- Organization
- Beth Israel Deaconess Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Alvaro Pascual-Leone, MD, PhD
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology
Study Record Dates
First Submitted
September 24, 2013
First Posted
November 5, 2013
Study Start
September 1, 2013
Primary Completion
October 1, 2016
Study Completion
November 1, 2016
Last Updated
May 30, 2017
Results First Posted
May 30, 2017
Record last verified: 2017-04