Huntington's DiseaseNCT02216474
Brain Stimulation in Movement Disorders
A study testing Transcranial direct current stimulation in people with Huntington's Disease and Tourette Syndrome, run by Birmingham and Solihull Mental Health NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington's Disease, Tourette Syndrome
- What is being tested?
- Transcranial direct current stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
- 18-65 years of age for TS; 40-65 years of age for HD; 18-65 for controls
- English as a first language
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Neuropsychiatry, BSMHFT The Barberry
Birmingham, West Midlands, B15 2FG
About this study
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.
Read the detailed description
The procedure does not involve any surgery or hair removal. We simply put a small amount of electrode gel on your head and then hold two electrodes on the top of your head for a short period of time (15-20 minutes) while they generate a small electrical current. It is quite common for participants to feel a tingling or an itch near where the electrode is applied, but if so, this usually wears off within a few minutes. Previous research has shown this method can occasionally lead to mild side-effects (e.g. headache, nausea, fatigue, exacerbation of scalp skin conditions). However, there are no known harmful long term effects. The positive benefits of brain stimulation can include improving the functioning of the brain for a short while after the stimulation session, in a way that may help with things like memory problems. Some people may not notice any change, but an improvement may still be detected using tests of complex mental skills including memory tasks. It is also possible that mood symptoms (e.g. depressive thoughts) could improve. The study will explore these possibilities. Looking at whether brain stimulation can help with health symptoms can help us develop new treatments.
This trial will include patients with two different movement disorders: Tourette syndrome and Huntington's disease. In both of these conditions, changes deep within the brain can have a knock on effect on higher brain areas important for complex mental abilities, as well as brain areas involved in movement control. Participants will be male and female adults (aged 18-65). Patients will have either Tourette syndrome (as diagnosed according to current medical criteria) or Huntington's disease (diagnosed by a genetic test). Patients will have few (if any) signs of additional medical conditions. Healthy controls (who will be compared to patients) will have no current significant medical or psychiatric diagnoses, history of drug use or brain injury.
There will be least two separate appointments for you to attend the study center. We will first assess your mental abilities (e.g. memory, attention) and interview you about current mood or medical symptoms. Brain stimulation will be given to slightly different areas of the outer part of the brain, near the top and front of the head, for each patient group. You may be asked to take part in the trial where there is a no-treatment placebo condition, where the procedure will feel similar to real brain stimulation, but real brain stimulation will not take place. If you receive the placebo condition you will also receive real stimulation, but you will not know which condition is which. This means the effects of expectations are less likely to influence the results. After brain stimulation we will take measures of mental abilities, and compare them to measures taken before brain stimulation, to show whether brain stimulation has had a greater effect on mental abilities than expected by chance.
You may be asked to complete a simple task (e.g. remembering numbers) while having the brain stimulation, as it has been suggested that this could make the effects of stimulation more effective in improving mental skills. As the trial continues, some participants will be invited to have repeated sessions of stimulation over a few days (e.g. three appointments over three days in a row) to look at whether this could make the effects last longer. We will record the effects of brain stimulation on participant's mental skills, movement symptoms and mood, as well as any side effects. We will collect data about your symptoms and health conditions in order to look for relationships between these factors and the effects of brain stimulation. Finally, you may be asked to have a brain scan straight after receiving brain stimulation, so we can look for any changes in brain activity.
- Conditions
- Huntington's Disease, Tourette Syndrome
- Being tested
- Transcranial direct current stimulation
- Medical subject headings
- Huntington Disease, Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function (working memory, response inhibition)
Measured: 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)
Measured: 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)
Measured: From baseline to five minutes after brain stimulation and from baseline to two weeks after stimulation (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2018
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Huntington's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birmingham and Solihull Mental Health NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216474
- Sponsor's protocol ID
- 14/WM/0119-NRR1301
- Status last verified
- Jan 2020
- First submitted
- 12 Aug 2014
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28390970
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Stimulation in Movement Disorders
- ClinicalTrials.gov ID
- NCT02216474
- Acronym / sponsor ID
- 14/WM/0119-NRR1301
- Conditions
- Huntington's Disease, Tourette Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Birmingham and Solihull Mental Health NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- Sep 2014
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The procedure does not involve any surgery or hair removal. We simply put a small amount of electrode gel on your head and then hold two electrodes on the top of your head for a short period of time (15-20 minutes) while they generate a small electrical current. It is quite common for participants to feel a tingling or an itch near where the electrode is applied, but if so, this usually wears off within a few minutes. Previous research has shown this method can occasionally lead to mild side-effects (e.g. headache, nausea, fatigue, exacerbation of scalp skin conditions). However, there are no known harmful long term effects. The positive benefits of brain stimulation can include improving the functioning of the brain for a short while after the stimulation session, in a way that may help with things like memory problems. Some people may not notice any change, but an improvement may still be detected using tests of complex mental skills including memory tasks. It is also possible that mood symptoms (e.g. depressive thoughts) could improve. The study will explore these possibilities. Looking at whether brain stimulation can help with health symptoms can help us develop new treatments.
This trial will include patients with two different movement disorders: Tourette syndrome and Huntington's disease. In both of these conditions, changes deep within the brain can have a knock on effect on higher brain areas important for complex mental abilities, as well as brain areas involved in movement control. Participants will be male and female adults (aged 18-65). Patients will have either Tourette syndrome (as diagnosed according to current medical criteria) or Huntington's disease (diagnosed by a genetic test). Patients will have few (if any) signs of additional medical conditions. Healthy controls (who will be compared to patients) will have no current significant medical or psychiatric diagnoses, history of drug use or brain injury.
There will be least two separate appointments for you to attend the study center. We will first assess your mental abilities (e.g. memory, attention) and interview you about current mood or medical symptoms. Brain stimulation will be given to slightly different areas of the outer part of the brain, near the top and front of the head, for each patient group. You may be asked to take part in the trial where there is a no-treatment placebo condition, where the procedure will feel similar to real brain stimulation, but real brain stimulation will not take place. If you receive the placebo condition you will also receive real stimulation, but you will not know which condition is which. This means the effects of expectations are less likely to influence the results. After brain stimulation we will take measures of mental abilities, and compare them to measures taken before brain stimulation, to show whether brain stimulation has had a greater effect on mental abilities than expected by chance.
You may be asked to complete a simple task (e.g. remembering numbers) while having the brain stimulation, as it has been suggested that this could make the effects of stimulation more effective in improving mental skills. As the trial continues, some participants will be invited to have repeated sessions of stimulation over a few days (e.g. three appointments over three days in a row) to look at whether this could make the effects last longer. We will record the effects of brain stimulation on participant's mental skills, movement symptoms and mood, as well as any side effects. We will collect data about your symptoms and health conditions in order to look for relationships between these factors and the effects of brain stimulation. Finally, you may be asked to have a brain scan straight after receiving brain stimulation, so we can look for any changes in brain activity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham transcranial direct current stimulation (frontal cortex) | Sham comparator | Other: Transcranial direct current stimulationTranscranial direct current stimulation will be ramped up over 60 seconds and then ramped down gradually to encourage blinding to condition. |
| Anodal transcranial DC stimulation (frontal cortex) | Experimental | Other: Transcranial direct current stimulationAnodal transcranial direct current stimulation to prefrontal cortex for approximately 15 minutes plus ramp up and down time |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
- 18-65 years of age for TS; 40-65 years of age for HD; 18-65 for controls
- English as a first language
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulation | Other | Anodal transcranial DC stimulation (frontal cortex), Sham transcranial direct current stimulation (frontal cortex) |
Primary outcome
Change in cognitive function (working memory, response inhibition)
Time frame: From baseline to five minutes after brain stimulation and from baseline to two weeks after stimulation (follow-up)
2 secondary outcomes
Change in motor symptom severity (tics/chorea)
Time frame: 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)
Time frame: From baseline to five minutes after brain stimulation and from baseline to two weeks after stimulation (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Derived from this study: PubMed 28390970Eddy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Huntington's Disease and Tourette Syndrome, run by Birmingham and Solihull Mental Health NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function (working memory, response inhibition) (time frame: From baseline to five minutes after brain stimulation and from baseline to two weeks after stimulation (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02216474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.