Trial record 6 of 38 for:    Open Studies | "Ataxia"

Transcranial Magnetic Stimulation in Spino-Cerebellar Ataxia (TMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01975909
First received: September 24, 2013
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Spinocerebellar Ataxia
Device: Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation (TMS) in Spino-Cerebellar Ataxia

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from baseline to post treatment on the Timed 25-Foot Walk [ Time Frame: Baseline and 1 week post treatment ] [ Designated as safety issue: No ]
    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.

  • Change from baseline to post treatment on the 9-hole peg test [ Time Frame: Baseline and 1 week post treatment ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Change from baseline to post treatment on Biomechanical Assessments [ Time Frame: Baseline and 1 week post treatment ] [ Designated as safety issue: No ]

    Gait - 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.

    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).

    Mobility and turning - 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.



Estimated Enrollment: 20
Study Start Date: September 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Transcranial Magnetic Stimulation
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 Name: Magstim 200
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.
Device: Transcranial Magnetic Stimulation
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 Name: Magstim 200

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

    1. The patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other CNS active drugs.
    2. 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:

    1. Known metal in the head (such as a surgical aneurysm clip) or a history of prior neurosurgical procedures.
    2. 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.
    3. Subjects who have or might have bullet fragments or other shrapnel (veterans or workers exposed to metal in their work environment).
    4. Subjects with metallic paint (e.g. color contact lenses, tattoos, metallic eyeliner)
    5. Subjects expressing significant claustrophobia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975909

Contacts
Contact: Seth Wakefield, MS 617-667-0209 swakefie@bidmc.harvard.edu
Contact: Ann Connor, RN, MS 617-667-0269 aconnor@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Sub-Investigator: Patricia Greenstein, MD         
Sub-Investigator: Bradley Manor, PhD         
Principal Investigator: Alvaro Pascual-Leone, MD, PhD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Alvaro Pascual-Leone, MD, PhD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01975909     History of Changes
Other Study ID Numbers: 2013P-000233, 1R21NS085491-01
Study First Received: September 24, 2013
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Spinocerebellar Ataxia
SCA
Ataxia
Transcranial Magnetic Stimulation
TMS

Additional relevant MeSH terms:
Ataxia
Cerebellar Ataxia
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 18, 2014