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Dystonia clinical trials

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NCT ID: NCT00148889 Completed - Cervical Dystonia Clinical Trials

Double-blind, Multicenter Study to Assess the Efficacy of Bilateral Pallidal Stimulation in Patients With Medically Refractory Primary Cervical Dystonia

Start date: July 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the efficacy and safety of bilateral pallidal stimulation in patients with medically refractory primary cervical dystonia.

NCT ID: NCT00142259 Active, not recruiting - Dystonia Clinical Trials

Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental Dystonia

Start date: October 2002
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of bilateral deep brain stimulation of the internal globus pallidus for treating idiopathic generalized or severe segmental dystonia.

NCT ID: NCT00137384 Completed - Focal Dystonia Clinical Trials

Movement-Related Brain Networks Involved in Hand Dystonia

Start date: August 25, 2005
Phase:
Study type: Observational

This study will use various methods to measure the activity of the motor cortex (the part of the brain that controls movements) in order to learn more about focal hand dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In focal dystonia, just one part of the body, such as the hand, neck or face, is involved. Patients with focal hand dystonia and healthy normal volunteers between 18 and 65 years of age may be eligible for this study. Each candidate is screened with a medical history, physical examination and questionnaire. Participants undergo the following procedures: Finger Movement Tasks Subjects perform two finger movement tasks. In the first part of the study, they move their index finger repetitively from side to side at 10-second intervals for a total of 200 movements in four blocks of 50 at a time. In the second part of the study, subjects touch their thumb to the other four fingers in sequence from 1, 2, 3 and 4, while a metronome beats 2 times per second to help time the movements. This sequence is repeated for a total of 200 movements in four blocks of 50 at a time. Electroencephalography This test records brain waves. Electrodes (metal discs) are placed on the scalp with an electrode cap, a paste or a glue-like substance. The spaces between the electrodes and the scalp are filled with a gel that conducts electrical activity. Brain waves are recorded while the subject performs a finger movement task, as described above. Magnetoencephalography MEG records magnetic field changes produced by brain activity. During the test, the subjects are seated in the MEG recording room and a cone containing magnetic field detectors is lowered onto their head. The recording may be made while the subject performs a finger task. Electromyography Electromyography (EMG) measures the electrical activity of muscles. This study uses surface EMG, in which small metal disks filled with a conductive gel are taped to the skin on the finger. Magnetic resonance imaging MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The patient lies on a table that can slide in and out of the scanner (a narrow metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning. Most scans last between 45 and 90 minutes. Subjects may be asked to lie still for up to 30 minutes at a time, and can communicate with the MRI staff at all times during the procedure. Questionnaire This questionnaire is designed to detect any sources of discomfort the subject may have experienced during the study.

NCT ID: NCT00132990 Completed - Cervical Dystonia Clinical Trials

A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia

Start date: February 2003
Phase: N/A
Study type: Interventional

The purposes of this study are: - to determine if bilateral pallidal deep brain stimulation results in improvement in neck postures/movements; - to determine if bilateral pallidal deep brain stimulation results in improvement in quality of life; and - to document the adverse effects of surgery in patients with cervical dystonia.

NCT ID: NCT00132340 Completed - Cervical Dystonia Clinical Trials

Deep Brain Stimulation to Treat Cervical Dystonia

Start date: August 2005
Phase: Phase 1
Study type: Interventional

This study will evaluate the effectiveness of deep brain stimulation (DBS) for treating primary dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. Medical therapies are available, but not all patients get adequate relief from the abnormal movements or the pain associated with them. DBS is a surgical procedure that interrupts neuronal circuits in the globus pallidus interna (Gpi) and subthalamic nucleus (STN) - areas of the basal ganglia of the brain that do not work correctly in patients with dystonia. This results in decreased movement and therefore may lessen patients' symptoms and pain. The study will also examine the physiology of dystonia and determine whether the treatment effects of DBS in the Gpi differ significantly from DBS of the STN. Patients 18 years of age and older with primary cervical dystonia that does not respond to medical treatment or botulinum toxin (Botox) may be eligible for this study. Candidates are screened with blood and urine tests, chest x-ray, electrocardiogram, and magnetic resonance imaging (MRI, see below) of the brain. Each participant undergoes the following tests and procedures: - Magnetic resonance imaging. This procedure is done after implantation of the stimulators to verify position of the electrodes. MRI uses a magnetic field and radio waves to produce images of the brain. The patient lies on a table that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure usually lasts about 45 to 90 minutes, during which the patient is asked to lie still for up to 15 minutes at a time. - Transcranial magnetic stimulation. This procedure maps brain function. A wire coil is held on the scalp, and a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the patient may be asked to tense certain muscles slightly or perform other simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the patient may hear a click and feel a pulling sensation on the skin under the coil. During the stimulation, electrical activity of muscles is recorded with a computer, using electrodes attached to the skin with tape. - Neurologic evaluation. Before and after DBS, the patient's dystonia is measured with a standardized rating scale called the Toronto Western Spasmodic Torticollis Scale (TWSTRS). - DBS treatment. Patients are randomly assigned to have electrodes implanted in either the Gpi or STN area of the basal ganglia. The electrodes are what stimulate the brain in DBS therapy. Before surgery, a frame is secured to the patient's head, and an MRI scan is done. DBS involves making two small incisions and two small holes in the skull, opening the lining around the brain, locating the Gpi or STN, securing the electrodes in place, and connecting them to the pulse generator that is placed under the skin below the collar bone. In addition, during the surgery, the patient is asked to move certain muscles. The muscle activity is recorded to gain a better understanding of the physiology of movement. After surgery, MRI scans are done to confirm placement of the electrodes. - Stimulation and evaluation. After surgery, patients' movements are evaluated during and after stimulation. The changes in movement and function are videotaped and scored according to a rating scale. The optimal stimulation settings are determined and the stimulators are adjusted accordingly. Neurologic evaluations with the TWSTRS scale are repeated at 1, 2, 3, 6 and 12 months after surgery, and the stimulators are adjusted as needed. Some of the evaluations are videotaped.

NCT ID: NCT00122044 Completed - Dystonia Clinical Trials

Childhood Hypertonia of Central Origin: A Trial of Anticholinergic Treatment Effects

Start date: January 2003
Phase: Phase 2
Study type: Interventional

This study is an open-label trial of trihexyphenidyl in children with upper extremity dystonia due to cerebral palsy. It is hypothesized that trihexyphenidyl in doses up to 0.75mg/kg/day would be well-tolerated and show significant changes on the Melbourne scale of upper extremity function.

NCT ID: NCT00118586 Completed - Healthy Clinical Trials

Neuropathology of Spasmodic Dysphonia

Start date: July 14, 2005
Phase:
Study type: Observational

This study will look for abnormalities in a brain of persons affected with spasmodic dysphonia, a form of movement disorder that involves involuntary "spasms" of the muscles in the vocal folds causing breaks of speech and affecting voice quality. The causes of this disorder are not known. The study will compare results of magnetic resonance imaging (MRI) in people with spasmodic dysphonia and in healthy volunteers. People with adductor or abductor spasmodic dysphonia and healthy volunteers may be eligible for this study. Candidates are screened with a medical history, physical examination, and a test called nasolaryngoscopy. For this test, the inside of the subject's nose is sprayed with a decongestant, and a small, flexible tube called a nasolaryngoscope is passed through the nose to the back of the throat to allow examination of the larynx (voice box). During this procedure, the subject is asked to perform tasks such as talking, singing, whistling, and saying prolonged vowels. The nasolaryngoscope is connected to a camera to record the movements of the vocal folds during these tasks. Eligible participants then undergo MRI of the brain. MRI uses a strong magnetic field and radio waves instead of x-rays to obtain images of body organs and tissues. For this test, the subject lies on a table that slides into the MRI scanner, a narrow metal cylinder, wearing ear plugs to muffle loud knocking sound that occurs during the scan. During MRI anatomical images of the brain are obtained. Subject may be asked to participate in up to two scanning sessions. Each session takes about 1-1/2 hours. Participants may also be asked to volunteer for a brain donation program which is optional. Information gained from donated tissue may lead to better treatments and potential cures for spasmodic dysphonia.

NCT ID: NCT00106782 Completed - Dystonia Clinical Trials

Transcranial Electrical Polarization to Treat Focal Hand Dystonia

Start date: March 18, 2005
Phase: Phase 2
Study type: Interventional

This study will evaluate the effect of transcranial electrical polarization (TEP), also called direct current (DC) stimulation, on focal hand dystonia in people with writer's cramp. In dystonia, muscle spasms cause uncontrolled twisting and repetitive movement or abnormal postures. Focal dystonia involves just one part of the body, such as the hand, neck or face. When people with focal hand dystonia make small and repeated movements with their hands, there is extra activity in the part of the brain called the motor cortex. TEP is a method of brain stimulation that slows down the activity of the nerve cells in the motor cortex. This study may help researchers develop new ways to treat focal hand dystonia. People 18 years of age and older with focal hand dystonia may be eligible for this study. Participants have a neurological examination and are randomly assigned to one of two treatment groups: TEP or placebo stimulation. The TEP group receives stimulation to the parts of the brain used for hand movement, and the placebo group receives sham stimulation, which does not affect any area of the brain. There are three TEP/placebo sessions over a period of 7 to 10 days. The first session may last up to 2-1/2 hours; the other two sessions last 1-2 hours. For TEP, sponge electrodes are placed on the scalp and an electrical current is passed through the scalp and skull to the outer part of brain. Before and after each session, participants have a neurological examination, including an evaluation of the rate and severity of their movement problems. For this assessment, participants do a writing test while the electrical activity of their hand muscles is recorded using surface electromyography (EMG). For EMG, small metal disks (electrodes) filled with a conductive gel are taped to the skin over the muscles being tested. Patients are followed in the clinic the day after the end of TEP treatment for evaluation of their movement abilities and the effects of therapy, such as improvement of handwriting.

NCT ID: NCT00105430 Completed - Dystonia Clinical Trials

Deep Brain Stimulation for Cervical Dystonia

Start date: March 2005
Phase: Phase 2
Study type: Interventional

This study will evaluate the effectiveness of deep brain stimulation (DBS) in treating primary generalized dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. Medical therapies are available, but not all patients get adequate relief from the abnormal movements or the pain associated with them. DBS is a surgical procedure that interrupts neuronal circuits in the Gpi and STN, areas of the basal ganglia of the brain that do not work correctly in patients with dystonia. The surgery results in decreased movement and therefore may lessen patients' symptoms and pain. Patients 7 years of age and older with generalized dystonia that does not respond to medical treatment may be eligible for this study. Candidates are screened with blood and urine tests, chest x-ray, and an electrocardiogram in patients 35 years of age or more. Participants undergo the following tests and procedures: - Magnetic resonance imaging. MRI uses a magnetic field and radio waves to produce images of the brain. The patient lies on a table that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure usually lasts about 45 to 90 minutes, during which the patient is asked to lie still for up to 15 minutes at a time. - Transcranial magnetic stimulation. This procedure maps brain function. A wire coil is held on the scalp, and a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the patient may be asked to tense certain muscles slightly or perform other simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the patient may hear a click and feel a pulling sensation on the skin under the coil. During the stimulation, electrical activity of muscles is recorded with a computer, using electrodes attached to the skin with tape. - Neurologic evaluation. Before and after DBS, the patient's dystonia, including voice strength and difficulty swallowing, are measured with a standardized rating scale. - DBS treatment. Patients are randomly assigned to have electrodes implanted in either the Gpi or STN area of the basal ganglia. The electrodes are what stimulate the brain in DBS therapy. Before surgery, a frame is secured to the patient's head, and an MRI scan is done. DBS involves making two small incisions and two small holes in the skull, opening the lining around the brain, locating the Gpi or STN, securing the electrodes in place and connecting them to the pulse generator that is placed under the skin below the collar bone. Additionally, during the surgery, the patient is asked to move certain muscles. The muscle activity is recorded to gain a better understanding of the physiology of movement. After surgery, computed tomography (CT) and MRI scans are done to confirm placement of the electrodes. - Stimulation and evaluation. After surgery, patients' movements are evaluated during and after stimulation. The changes in movement and function are videotaped and scored according to a rating scale. The optimal stimulation settings are determined and the stimulators are adjusted accordingly. - Follow-up. Patients are evaluated, with videotaping, at 1, 2, 3, 6, 12, 18 and 24 months after surgery, and the stimulators are adjusted as needed.

NCT ID: NCT00102999 Completed - Dystonia Clinical Trials

Brain Function in Focal Dystonia

Start date: January 31, 2005
Phase: N/A
Study type: Observational

Objectives The main objectives of this proposal are (1) to characterize motor learning abnormalities in patients with focal dystonia; (2) to show, using transcranial magnetic stimulation, that this abnormal motor learning went together with an impaired modulation by somatosensory inputs of short and long-interval paired-pulse inhibitions (sICI, lICI) and facilitations (sICF, ICF) of MEPs (ICIs and ICFs are thought to reflect activity of inhibitory and excitatory interneuron's in the primary motor cortex M1); (3) to show that abnormalities of long-term potentiation and long-term depression (LTP/LTD)-like mechanisms (tested using a paired associative stimulation (PAS) intervention), thought to play a crucial role in learning, are associated in dystonia with an abnormal modulation of ICIs and ICFs by somatosensory inputs. Study population 30 patients with a focal upper limb dystonia and 45 healthy volunteers will take part in the main study. 7 patients with a focal upper limb dystonia and 12 healthy volunteers will take part in the control study. Design In the main study: subjects will complete 5 different sessions: visit 1: clinical screening, 1 hour; visit PAS session, 3 hours; visit 3: a minimum of 7 days later, motor learning session, 3 hours; visit 4: follow-up 24 hours later, 1 hour and a half; visit 5, follow-up 48 hours later, 1 hour and a half. During the PAS session they will receive 15 minutes of repeated paired stimulations (transcranial magnetic stimulation -TMS- and peripheral stimulation) thought to produce LTP/LTD like phenomena in M1. During the motor learning sessions they will be asked to perform, as fast as possible, a metronome-paced (0.5 Hz) pinch of their index finger and thumb. They will have 3 blocks of motor practice during the motor learning session. Between each block of motor practice and before and after PAS, while they rest, subjects will receive paired-pulse transcranial magnetic stimulations (TMS) associated or not with peripheral nerve stimulation in order to assess interactions at M1 cortical level between somatosensory incoming volleys and intracortical inhibitory and excitatory interneuron's. In the control study: subjects will complete a unique session. They will receive a PAS intervention. Before and after the PAS intervention, spinal excitability will be tested by the means of H reflexes evoked in wrist flexor muscles. Outcome measures: The behavioral effect of the motor training or of the PAS intervention will be assessed by measuring the mean peak acceleration (MPA) of thumb movement during the blocks of motor practice and the mean maximal peak force (MPF) between the index finger and thumb before and after the blocks of motor practice. The activity of different sets of intracortical interneurons (short and long interval GABA related inhibitions: sICI, lICI, intracortical glutamate-related facilitation: ICF and short interval facilitation: sICF) can be tested using paired-pulse TMS paradigms. The effect of learning (or of PAS intervention) on the interaction between somatosensory afferent input and intracortical processes will be assessed by comparing the amount of sICI, lICI, ICF and sICF when associated or not with a peripheral nerve stimulation (median and ulnar nerve stimulation) in a trained muscle (flexor pollicis brevis: FPB) and a non-trained muscle (abductor digiti minimi: ADM) at different times during and after the motor learning or the PAS intervention. The effect of PAS on spinal cord excitability will be assessed by comparing the size of the H reflex before and after PAS.