Brain Stimulation in Movement Disorders

NCT02216474 | Completed DMC

• 1 other identifier: 14/WM/0119-NRR1301
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Brain stimulation in movement disorders This trial will explore the effects of very gentle electrical stimulation of the brain in patients with movement disorders. Other studies have already been carried out and have shown that brain stimulation may help to improve mental abilities and the symptoms of conditions such as depression and stroke. The investigators will show whether this method can help with symptoms such as memory and concentration problems in patients with movement disorder who have mild to moderate problems with these mental abilities. The investigators will also look at the effects of brain stimulation on movement symptoms and mood. These people will be compared to healthy people to help us understand whether brain stimulation works differently in healthy people and people with brain disorders. This trial is being carried out at one centre in Birmingham. It is scheduled to begin in September 2014 and will last for up to five years. As the study commences it is being funded by Birmingham and Solihull Mental Health Foundation Trust and University of Birmingham. The investigators plan to recruit up to a maximum of 200 individuals in this study.

Conditions

Huntington's Disease; Tourette Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in cognitive function (working memory, response inhibition)

  From baseline to five minutes after brain stimulation and from baseline to two weeks after stimulation (follow-up)

Secondary Outcomes (2)

• Change in motor symptom severity (tics/chorea)

  From baseline to five minutes after brain stimulation and from baseline to two weeks after stimulation (follow-up)

• Mood change (anxiety and depression questionnaire scores)

  From baseline to five minutes after brain stimulation and from baseline to two weeks after stimulation (follow-up)

Study Arms (2)

Sham transcranial direct current stimulation (frontal cortex)

SHAM COMPARATOR

Transcranial direct current stimulation will be ramped up over 60 seconds and then ramped down gradually to encourage blinding to condition.

Other: Transcranial direct current stimulation

Anodal transcranial DC stimulation (frontal cortex)

EXPERIMENTAL

Anodal transcranial direct current stimulation to prefrontal cortex for approximately 15 minutes plus ramp up and down time

Other: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation OTHER

Anodal transcranial DC stimulation (frontal cortex); Sham transcranial direct current stimulation (frontal cortex)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will have either Tourette syndrome (TS) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders criteria or Huntington's disease (HD) diagnosed genetically
• Controls will be generally healthy individuals not taking any psychoactive medications and without diagnosed psychiatric or serious medical conditions (e.g. history of seizures, heart disease, head injury)
• years of age for TS; 40-65 years of age for HD; 18-65 for controls
• English as a first language

You may not qualify if:

• No current significant co-morbid psychiatric disorder (e.g. learning disability, schizophrenia) or medical condition which may contraindicate brain stimulation or magnetic resonance imaging (e.g. epilepsy, chronic heart disease, scalp skin conditions, metal skull implants). Mild symptoms of obsessive compulsive disorder, attention deficit hyperactivity disorder and/or mood disorders will be accepted as these are very common
• No contraindications to MRI scanning (if they will be scanned) such as metal in the body, claustrophobia or seizure history
• No complex medication regimes (e.g. combinations of multiple dopaminergic drugs plus selective serotonin reuptake inhibitors

Sponsors & Collaborators

• Birmingham and Solihull Mental Health NHS Foundation Trust: lead
• University of Birmingham: collaborator

Study Sites (1)

Department of Neuropsychiatry, BSMHFT The Barberry

Birmingham, West Midlands, B15 2FG, United Kingdom

Location

Related Publications (1)

• Eddy CM, Shapiro K, Clouter A, Hansen PC, Rickards HE. Transcranial direct current stimulation can enhance working memory in Huntington's disease. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Jul 3;77:75-82. doi: 10.1016/j.pnpbp.2017.04.002. Epub 2017 Apr 5.

  PMID: 28390970 DERIVED

MeSH Terms

Conditions

Huntington Disease; Tourette Syndrome

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Tic Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 15, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

GB (1)