- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01975909
Transcranial Magnetic Stimulation in Spino-Cerebellar Ataxia (TMS)
Transcranial Magnetic Stimulation (TMS) in Spino-Cerebellar Ataxia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Spinocerebellar Ataxia (SCA) refers to a family of genetic diseases that cause progressive problems with gait and balance, as well as other debilitating symptoms. There is no cure for SCA and a lack of an effective symptomatic treatment.
Investigators will recruit 20 patients with genetically-confirmed SCA to use a novel approach - noninvasive transcranial magnetic stimulation (TMS) - to improve balance, gait, and posture in patients with SCA. Half will be randomly assigned to a real intervention, and half to a sham (control) intervention. The TMS intervention will consist of 20 stimulation sessions over a four week period. At baseline and follow-up, patients will undergo comprehensive assessments including several SCA rating scales, along with sophisticated tests of balance (ie. walking, standing, and muscle coordination). Patients will also complete a series of neurophysiologic tests to evaluate the function of the cerebellum and its connections before and after the intervention.
Investigators anticipate patients receiving real TMS will show better balance, fewer falls, and improved mobility, while those undergoing sham stimulation will show no benefits. If our prediction is correct, this study will provide evidence-based support for a new treatment to improve the lives of patients with SCA.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
No medication is an absolute exclusion from TMS. Medications will be reviewed by the responsible MD and a decision about inclusion will be made based on the following:
- 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.
TMS and MRI-Specific exclusion criteria including:
- 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).
- Subjects with metallic paint (e.g. color contact lenses, tattoos, metallic eyeliner)
- Subjects expressing significant claustrophobia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Transcranial Magnetic Stimulation (TMS)
A 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.
|
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.
Other Names:
|
Sham Comparator: Sham Transcranial Magnetic Stimulation
A 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA)
Time Frame: Baseline and 1 week post treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline to Post Treatment on the Timed 25-Foot Walk
Time Frame: Baseline and 1 week post treatment
|
A quantitative assessment of mobility and leg function.
Two trials of patients walking along a 25ft course as quickly and safely as possible.
Time taken to complete course will be recorded and averaged across trials.
|
Baseline and 1 week post treatment
|
Percent Change From Baseline to Post Treatment on the 9-hole Peg Test
Time Frame: Baseline and 1 week post treatment
|
The test consists of a block with nine holes, into which the subject places and then removes 9 pegs.
The time taken to complete the test will be recorded.
|
Baseline and 1 week post treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline to Post Treatment on Gait Speed in 90 Second Walking Test
Time Frame: Baseline and 1 week post treatment
|
Two 90 second trials of walking at a preferred speed along a 80x4m indoor hallway.
A wireless Noraxon DTS system (Noraxon Inc, Scottsdale, AZ) will be used simultaneously and continuously record bilateral foot placements, 3-dimensional trunk accelerations, and lower-extremity surface electromyography of eight muscles.
|
Baseline and 1 week post treatment
|
Percent Change From Baseline to Post Treatment on Standing Postural Control
Time Frame: Baseline and 1 week post treatment
|
Postural control - assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during two, 30second trials of standing with eyes open on a stationary force platform (AMTI, Watertown, MA).
|
Baseline and 1 week post treatment
|
Percent Change From Baseline to Post Treatment on Mobility and Turning
Time Frame: Baseline and 1 week post treatment
|
Mobility and turning is assessed by the timed up-and-go test (Podsiadlo & Richardson, 1991).
The participant will be seated in an armed chair.
On the word "go," the subject will stand up using the arm rests if needed, walk (with assistive device if needed) around a cone placed three meters in front of the chair, return and sit down as quickly as possible.
|
Baseline and 1 week post treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alvaro Pascual-Leone, MD, PhD, Beth Israel Deaconess Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Dyskinesias
- Spinal Cord Diseases
- Heredodegenerative Disorders, Nervous System
- Cerebellar Diseases
- Ataxia
- Cerebellar Ataxia
- Spinocerebellar Ataxias
- Spinocerebellar Degenerations
Other Study ID Numbers
- 2013P000233
- 1R21NS085491-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinocerebellar Ataxia
-
Cadent TherapeuticsWithdrawnSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxias | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | Spinocerebellar Ataxia Type 10 | Spinocerebellar Ataxia Type 7 | Spinocerebellar Ataxia Type 8 | Spinocerebellar Ataxia Type 17 | ARCA1 - Autosomal Recessive...United States
-
Biohaven Pharmaceuticals, Inc.Active, not recruitingSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxias | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | Spinocerebellar Ataxia Type 10 | Spinocerebellar Ataxia Type 7 | Spinocerebellar Ataxia Type 8United States, China
-
Biohaven Pharmaceuticals, Inc.Active, not recruitingSpinocerebellar Ataxias | Spinocerebellar Ataxia Genotype Type 1 | Spinocerebellar Ataxia Genotype Type 2 | Spinocerebellar Ataxia Genotype Type 3 | Spinocerebellar Ataxia Genotype Type 6 | Spinocerebellar Ataxia Genotype Type 7 | Spinocerebellar Ataxia Genotype Type 8 | Spinocerebellar Ataxia Genotype...United States
-
Teachers College, Columbia UniversityActive, not recruitingSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | Spinocerebellar Ataxia Type 7United States
-
Sclnow Biotechnology Co., Ltd.Not yet recruitingSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6
-
University of California, Los AngelesActive, not recruitingSpinocerebellar Ataxias | Spinocerebellar Ataxia 3 | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | MSA-CUnited States
-
University of FloridaAcorda TherapeuticsCompletedSpinocerebellar Ataxias Type 1 | Spinocerebellar Ataxias Type 2 | Spinocerebellar Ataxias Type 3 | Spinocerebellar Ataxias Type 6United States
-
University of ChicagoPfizer; Biogen; APDM Wearable TechnologiesActive, not recruitingSpinocerebellar Ataxia Type 3 | Friedreich Ataxia | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6United States
-
University of FloridaUniversity of California, Los Angeles; National Ataxia FoundationRecruitingSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6United States
-
Assistance Publique - Hôpitaux de ParisCompletedSpinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia, Autosomal Recessive 3 | Episodic Ataxia, Type 7France
Clinical Trials on Transcranial Magnetic Stimulation
-
Russian Academy of Medical SciencesCompletedStrokeRussian Federation
-
State University of New York - Upstate Medical...RecruitingHeadache | Brain Concussion | Mild Traumatic Brain Injury | Post-Concussion SymptomsUnited States
-
George Mason UniversityMedStar National Rehabilitation NetworkCompletedStroke | Stroke, Ischemic | Hemiparesis | Cerebral Vascular AccidentUnited States
-
Centre hospitalier de l'Université de Montréal...Canadian Institutes of Health Research (CIHR)RecruitingMajor Depressive DisorderCanada
-
University Hospital TuebingenFederal Ministry of Health, Germany; University of Ulm; Department of Psychiatry... and other collaboratorsRecruitingMajor Depressive DisorderGermany
-
VA Office of Research and DevelopmentRecruitingDepression | Gulf War IllnessUnited States
-
National Institute of Mental Health (NIMH)CompletedHealthy VolunteersUnited States
-
University of ManitobaManitoba Medical Service FoundationSuspendedObsessive Compulsive DisorderCanada
-
Beth Israel Deaconess Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
VA Office of Research and DevelopmentBrown University; VA Palo Alto Health Care SystemActive, not recruiting