Overview

This trial is active, not recruiting.

Condition spinocerebellar ataxia
Treatment transcranial magnetic stimulation
Sponsor Beth Israel Deaconess Medical Center
Collaborator National Institute of Neurological Disorders and Stroke (NINDS)
Start date September 2013
End date December 2015
Trial size 20 participants
Trial identifier NCT01975909, 1R21NS085491-01, 2013P-000233

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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.
transcranial magnetic stimulation Magstim 200
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.
(Sham Comparator)
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.
transcranial magnetic stimulation Magstim 200
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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Change from baseline to post treatment on the Timed 25-Foot Walk
time frame: Baseline and 1 week post treatment
Change from baseline to post treatment on the 9-hole peg test
time frame: Baseline and 1 week post treatment

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title Transcranial Magnetic Stimulation (TMS) in Spino-Cerebellar Ataxia
Principal investigator Alvaro Pascual-Leone, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.